0
selected
-
1.
Effect of the probiotic strain, Lactiplantibacillus plantarum P9, on chronic constipation: A randomized, double-blind, placebo-controlled study.
Ma, T, Yang, N, Xie, Y, Li, Y, Xiao, Q, Li, Q, Jin, H, Zheng, L, Sun, Z, Zuo, K, et al
Pharmacological research. 2023;191:106755
-
-
-
-
Free full text
-
Plain language summary
Chronic constipation (CC) is a common gastroenterological problem encountered in clinical practice, and it negatively impacts patients’ quality of life. Growing evidence indicates that the occurrence of CC is closely linked to gut dysbiosis. Several main probiotics have been used to relieve constipation. The main aim of this study was to systematically evaluate the beneficial effects of Lactiplantibacillus plantarum P9 (P9) administration on alleviating CC and impact on the host gut microbiota and its metabolites. This study was a 42-day longitudinal double-blind randomised controlled trial which enrolled a total of 181 patients with CC. Subjects were randomly assigned to the probiotic or placebo group. Subjects in P9 group received one sachet of P9 powder per day after meal. Results show that P9 administration significantly improved patients’ defecation frequency. In fact, P9 administration effectively alleviated constipation, and the symptom relief effects were linked to desired changes and interactions with different types of host microbes. Authors conclude that administering P9 could effectively relieve chronic constipation in adults and improve some aspects of their quality of life.
Expert Review
Conflicts of interest:
None
Take Home Message:
- This study suggested that P9-associated constipation symptom relief was not attributed to macroscopic changes in the host gut bacteriome and phageome
- However, results supported that taking P9 could alleviate constipation, with the symptom relief effects linked to desired changes and interactions with different types of host microbes, including the gut commensal bacteria (L. plantarum, Ruminococcus_B gnavus, Oscillospiraceae sp., Lachnospiraceae sp.) and the bacteriophage family, Herelleviridae.
Evidence Category:
-
X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
-
B: Systematic reviews including RCTs of limited number
-
C: Non-randomized trials, observational studies, narrative reviews
-
D: Case-reports, evidence-based clinical findings
-
E: Opinion piece, other
Summary Review:
Introduction
This study investigated the effect of a specific probiotic strain in alleviating Chronic Constipation (CC).
Methods
- The study employed a 42-day randomised control trial (RTC) double-blind, placebo-controlled design, with 163 patients, (mean age =22.68 ±5.66 years for the probiotic group and 21.59 ±4.59 years for the placebo group), diagnosed with CC (Rome IV criteria)
- The male to female ratio was 15–63 and 17–68 in probiotic and placebo groups respectively
- Groups were standardised with no differences observed in baseline age, gender ratio, drug treatment, high-fibre diet and smoking between the two groups (P >0.18)
- Participants were randomly assigned to the probiotic Lactiplantibacillis plantarum P9 (n=78; 2 g per sachet, 1 ×1011 CFU/day) or the placebo (n =85; maltodextrin powder) groups.
Results
Primary outcomes: weekly mean complete spontaneous bowel movements (CSBMs):
- At 28-days CSBM was 28% higher in the P9 group (P=0.039) compared with the placebo group
- At 42-days CSBM remained significantly higher in the P9 group (P=0.026) compared with the placebo group, and increased 2-fold compared with baseline (P <0.05)
- Authors noted that the CSBM benefits were maintained even after 14 days of not taking the supplement.
Secondary outcomes: The effects of P9 supplementation on constipation-related parameters, including the weekly mean frequency of spontaneous bowel movements (SBMs) demonstrated:
- After 28-days of P9 supplementation, SBMs were 12% higher than the placebo group (P=0.039)
- No differences were observed in the weekly mean stool consistency and straining scores between groups (P>0.05).
Patients’ quality of life and psychological state, using a PAC-QOL questionnaire related to: worries and concerns (WO), physical discomfort, psychosocial discomfort, and satisfaction and found:
- At day 14 WO in the P9 group was 1.22-fold lower than those in the placebo group (P <0.05)
- No differences in the other 3 items between P9 and placebo groups (P >0.05) were observed
- Supplementation resulted in a significant change in relative abundance of the P9 genome (≥0.01%)
- However, no differences were observed in alpha diversity after P9 consumption compared with placebo.
Conclusion
- The results indicated that P9 administration alleviated patients’ constipation symptoms and improved their quality of life but did not impact on gut bacteria or phageome
- Lactiplantibacillis plantarum P9 supplementation impacted several beneficial bacteria species (e.g. (Lactiplantibacillus plantarum and Ruminococcus_B gnavus), and reduced levels of other bacteria and phage taxa (e.g. Oscillospiraceae sp., Lachnospiraceae sp., and Herelleviridae) which may be implicated in constipation relief mechanisms.
Clinical practice applications:
- In this study, the use of P9 administration significantly improved patients’ defecation frequency which could have beneficial implications for patients suffering from chronic constipation
- Probiotic effects are known to be strain- and host-specific, and based on this study P9 administration for relief of constipation needs to be taken for at least two weeks to improve aspects of patients’ quality of life and 4 weeks for improvements in constipation.
Considerations for future research:
- Future trials should include factors that impact gut motility and constipation symptoms, such as: a detailed daily diet (dietary composition, fibre content, and water intake) and physical activity scale (intensity and duration), and longer term use of P9 or comparison across strains
- The relatively small study size and short duration of this study, as well as the younger age groups included may be pertinent when considering future research.
Abstract
Chronic constipation (CC) is a common gastrointestinal condition associated with intestinal inflammation, and the condition considerably impairs patients' quality of life. We conducted a large-scale 42-day randomized, double-blind, placebo-controlled trial to investigate the effect of probiotics in alleviating CC. 163 patients diagnosed with CC (following Rome IV criteria) were randomly divided into probiotic (n = 78; received Lactiplantibacillus plantarum P9 [P9]; 1 ×1011 CFU/day) and placebo (n = 85; received placebo material) groups. Ingesting P9 significantly improved the weekly mean frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs), while significantly reducing the level of worries and concerns (WO; P < 0.05). Comparing with the placebo group, P9 group was significantly enriched in potentially beneficial bacteria (Lactiplantibacillus plantarum and Ruminococcus_B gnavus), while depriving of several bacterial and phage taxa (Oscillospiraceae sp., Lachnospiraceae sp., and Herelleviridae; P < 0.05). Interesting significant correlations were also observed between some clinical parameters and subjects' gut microbiome, including: negative correlation between Oscillospiraceae sp. and SBMs; positive correlation between WO and Oscillospiraceae sp., Lachnospiraceae sp. Additionally, P9 group had significantly (P < 0.05) more predicted gut microbial bioactive potential involved in the metabolism of amino acids (L-asparagine, L-pipecolinic acid), short-/medium-chain fatty acids (valeric acid and caprylic acid). Furthermore, several metabolites (p-cresol, methylamine, trimethylamine) related to the intestinal barrier and transit decreased significantly after P9 administration (P < 0.05). In short, the constipation relief effect of P9 intervention was accompanied by desirable changes in the fecal metagenome and metabolome. Our findings support the notion of applying probiotics in managing CC.
-
2.
A Low-FODMAP Diet Provides Benefits for Functional Gastrointestinal Symptoms but Not for Improving Stool Consistency and Mucosal Inflammation in IBD: A Systematic Review and Meta-Analysis.
Peng, Z, Yi, J, Liu, X
Nutrients. 2022;14(10)
-
-
-
-
Free full text
Plain language summary
The low-FODMAP diet eliminates carbohydrates that cannot be easily digested in order to reduce functional gastrointestinal symptoms associated with irritable bowel disease (IBD). The symptoms of irritable bowel disease include abdominal pain and bloating. This systematic review and meta-analysis aimed to evaluate whether a low-FODMAP diet can alleviate functional gastrointestinal symptoms in individuals with inflammatory bowel disease. In comparison with a regular diet, a low-FODMAP diet significantly reduced symptoms of bloating, wind, flatulence, abdominal pain, fatigue, and lethargy in patients with IBD. In addition, patients with Crohn's disease have achieved remission or reduced symptoms after following a low-FODMAP diet. Healthcare professionals can use this study to understand better the effects of a low-FODMAP diet on patients with IBD who have functional gastrointestinal symptoms. Further robust studies are, however, required to evaluate the evidence's robustness and identify the mechanism behind the improvement of symptoms.
Expert Review
Conflicts of interest:
None
Take Home Message:
- LFD use in IBD improved symptoms of bloating, wind or flatulence, borborygmi, abdominal pain, and fatigue or lethargy, but not nausea and vomiting.
Evidence Category:
-
X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
-
B: Systematic reviews including RCTs of limited number
-
C: Non-randomized trials, observational studies, narrative reviews
-
D: Case-reports, evidence-based clinical findings
-
E: Opinion piece, other
Summary Review:
Introduction
This meta-analysis assesses the efficacy of a low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet (LFD) in inflammatory bowel disease [IBD: ulcerative colitis (UC) and Crohn’s disease (UC)] participants with functional gastrointestinal symptoms (FGSs).
Methods
A search was performed on PubMed, Web of Science, EMBASE, Cochrane Central Register of Controlled Trials, Chinese National Knowledge Infrastructure (CNKI), WanFang (Chinese) Database up to March 2022. Quality assessment of all included studies was performed.
Results
9 studies (4 randomised controlled trials, 5 non-randomised studies) with a total of 351 participants diagnosed with IBD were included, and compared LFD with a placebo diet or normal diet (ND), overall and individual
LFD Effects of FGS:
- Overall 9 studies: an improvement (0.47, 0.33–0.66, p = 0.0000)
- No difference in the subgroup classified by disease type
- CD and UC: no improvement
Individual improvement:
- Bloating (0.37, 0,24-0,57, p=0.0000); wind or flatulence (0.38, 0,28-0,51, p=0.0000); borborygmi (0.48, 0,26-0,89, p=0.0000), abdominal pain (0.5, 0,37-0,68, p=0.0000), fatigue/lethargy (0.71, 0,61-0,82, p=0.0000)
- No difference in nausea and vomiting (0.54, 0,22-1,32, p=018)
IBS Quality of Life Score:
- 2 studies: reduced Short IBD Questionnaire (SIBDQ) score (11.24, 6.61-15.87, p=0.0000)
Bristol Stool Form Chart:
- 2 studies: normal stool consistency (type 3-4); no difference (5.99, 0.17-216.51, p=0.33)
- 2 other studies: no difference (-0.17, 0.48 - 0.15, p=0.30)
Diseases activity (Harvey-Bradshaw index):
- 2 studies using the Mayo score: no difference (-32, -1,09-0.45, p=0.41)
- 3 studies using BHi score: reduction (-1.09, -1,77-0.42, p=0.002)
Faecal calprotectin:
- 2 studies: no change (-16.03, -36,78-4.73, p=0.13)
Limitations
- Comparison diets were not standardised, suggesting the potential of different dietary habits to bias results..
- Heterogeneity of included studies, and the relatively small sample size of the studies can reduce the reliability of the results.
Conclusion
While the study found inconsistent definition standards for FGS, all the nine studies showed that LFD was associated with an improvement in some symptoms.
Clinical practice applications:
- This study suggests that IBD patients with FGSs may benefit from LFD treatment with the assistance of a healthcare professional.
Considerations for future research:
- This study has shown that LFD can improve FGSs in IBD, but further research with a larger sample size and more comprehensive analysis is warranted to replicate the results.
- The description of the findings and Quality of Life data are a little unclear. The impact on Quality of Life warrants further investigation, as clinicians need to consider the impact of following a restrictive diet on Quality of Life.
Abstract
BACKGROUND A low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet (LFD) is claimed to improve functional gastrointestinal symptoms (FGSs). However, the role of LFD in inflammatory bowel disease (IBD) patients with FGSs remains unclear. OBJECTIVE To systematically assess the efficacy of LFD in IBD patients with FGSs. METHODS Six databases were searched from inception to 1 January 2022. Data were synthesized as the relative risk of symptoms improvement and normal stool consistency, mean difference of Bristol Stool Form Scale (BSFS), Short IBD Questionnaire (SIBDQ), IBS Quality of Life (IBS-QoL), Harvey-Bradshaw index (HBi), Mayo score, and fecal calprotectin (FC). Risk of bias was assessed based on study types. A funnel plot and Egger's test were used to analyze publication bias. RESULTS This review screened and included nine eligible studies, including four randomized controlled trials (RCTs) and five before-after studies, involving a total of 446 participants (351 patients with LFD vs. 95 controls). LFD alleviated overall FGSs (RR: 0.47, 95% CI: 0.33-0.66, p = 0.0000) and obtained higher SIBDQ scores (MD = 11.24, 95% CI 6.61 to 15.87, p = 0.0000) and lower HBi score of Crohn's disease (MD = -1.09, 95% CI -1.77 to -0.42, p = 0.002). However, there were no statistically significant differences in normal stool consistency, BSFS, IBS-QoL, Mayo score of ulcerative colitis, and FC. No publication bias was found. CONCLUSIONS LFD provides a benefit in FGSs and QoL but not for improving stool consistency and mucosal inflammation in IBD patients. Further well-designed RCTs are needed to develop the optimal LFD strategy for IBD.
-
3.
Predictors of Symptom-Specific Treatment Response to Dietary Interventions in Irritable Bowel Syndrome.
Colomier, E, Van Oudenhove, L, Tack, J, Böhn, L, Bennet, S, Nybacka, S, Störsrud, S, Öhman, L, Törnblom, H, Simrén, M
Nutrients. 2022;14(2)
-
-
-
-
Free full text
Plain language summary
Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction, formerly known as a functional gastrointestinal (GI) disorder. Apart from abdominal pain, altered stool frequency, diarrhoea, and constipation, a large proportion of patients with IBS also experience other GI symptoms such as abdominal distention, bloating and flatulence. The aim of this study was to investigate predictors of treatment response to the low FODMAP (short-chain carbohydrates, i.e., fermentable oligo-, di-, monosaccharides, and polyols) and the traditional IBS diet while focusing on the four core IBS symptoms (bloating, constipation, diarrhoea, and pain). This study was a post-hoc analysis of a previously published randomised controlled trial. In total, 33 patients on low FODMAP diet and 34 patients on the traditional IBS diet were included in the analysis. Results showed that patterns of psychological, dietary, and microbial factors can predict IBS symptom response to two dietary advice systems—the traditional IBS and the low FODMAP diet. A clinical profile with less severe IBS features appears to predict a better symptom-specific response to both dietary interventions. Authors conclude that larger prospective randomised controlled trials which include different treatment approaches are required as they may help to optimize personalized treatment algorithms in IBS.
Expert Review
Conflicts of interest:
None
Take Home Message:
- Dietary intervention for IBS related symptoms was efficacious for up to 75% of patients in this study
- Recommendation for a traditional IBS dietary intervention should supersede the low-FODMAP diet, with the latter only implemented when symptoms persist.
Evidence Category:
-
X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
-
B: Systematic reviews including RCTs of limited number
-
C: Non-randomized trials, observational studies, narrative reviews
-
D: Case-reports, evidence-based clinical findings
-
E: Opinion piece, other
Summary Review:
Introduction
This randomised controlled intervention study of 67 individuals fulfilling the Rome III criteria for IBS drew comparisons between the efficacy of the traditional IBS diet - as directed by the British Dietetic Association and National Institute for Health and Care Excellence (NICE) - and the low fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs) diet on specific IBS-related symptoms (pain, constipation, diarrhoea, and bloating).
Methods
A 10-day screening period included faecal sample analysis, 4-day food diary (pre-randomisation and last week of intervention), and daily stool diary (Bristol Stool Form scale). After 10 days, patients compiled several GI and non-GI related questionnaires, inclusive of IBS severity scoring system (IBS-SSS). Patients who scored ≥175 for the IBS-SSS were randomly allocated to follow either a low-FODMAP or traditional IBS diet for a period of 4-weeks. Thorough explanations were provided by trained Dietitians. During intervention, patients compiled symptom questionnaires (Gastrointestinal Symptoms Rating Scale-IBS) on a weekly basis.
Results
- Both diets reduced symptoms of pain, diarrhoea and bloating (all p<0.0001), but not constipation (p=0.15)
- There was no difference between following the traditional IBS diet and low-FODMAP diet in terms of pain (p=0.80), constipation (p=0.63), diarrhoea (p=0.96) and bloating (p=0.35)
- Less severe gut dysbiosis was weakly associated with better dietary response and improvement of constipation (p=0.05)
- Higher energy intake at baseline predicted better pain improvement with both dietary types compared to lower energy intake (p=0.03)
- More severe psychological distress predicted worse intervention response for bloating (p=0.03)
- Higher baseline oligosaccharide intake predicted a worse response to the low FODMAP diet (p=0.01) but not the traditional IBS diet (p=0.16).
Conclusion
This study demonstrated that based on 4 distinct IBS-related symptomatology, better treatment response to 2 different dietary strategies was noted in patients with less severe clinical characteristics. Higher energy intake at baseline and gut dysbiosis scores that were similar to healthy controls were associated with better improvements following dietary interventions. Thus patients who already follow a calorie restricted diet and who have more significant gut dysbiosis profiles might need more bespoke intervention. Severe psychological distress patients responded worse to both diets.
Clinical practice applications:
- Even a short 4-week specific dietary intervention (low FODMAP or traditional IBS diet) can result in IBS-related symptomatic improvement for pain, bloating, and diarrhoea, but not constipation
- The preferred starting point for dietary intervention should be the traditional IBS diet given its relative ease to follow
- The more restrictive low FODMAP protocol could be considered if symptoms persist
- More bespoke interventions are required for patients who suffer with severe psychological stress, have tested and found gut dysbiosis, and individuals who already follow a restrictive diet.
Considerations for future research:
- Future studies need to include not only larger but more diverse cultural and socio-economic cohorts to ascertain the efficacy of IBS symptom-related dietary interventions
- Longer periods of intervention are needed to confirm dietary intervention efficacy.
Abstract
(1) Background: Predictors of dietary treatment response in irritable bowel syndrome (IBS) remain understudied. We aimed to investigate predictors of symptom improvement during the low FODMAP and the traditional IBS diet for four weeks. (2) Methods: Baseline measures included faecal Dysbiosis Index, food diaries with daily energy and FODMAP intake, non-gastrointestinal (GI) somatic symptoms, GI-specific anxiety, and psychological distress. Outcomes were bloating, constipation, diarrhea, and pain symptom scores treated as continuous variables in linear mixed models. (3) Results: We included 33 and 34 patients on the low FODMAP and traditional IBS diet, respectively. Less severe dysbiosis and higher energy intake predicted better pain response to both diets. Less severe dysbiosis also predicted better constipation response to both diets. More severe psychological distress predicted worse bloating response to both diets. For the different outcomes, several differential predictors were identified, indicating that baseline factors could predict better improvement in one treatment arm, but worse improvement in the other treatment arm. (4) Conclusions: Psychological, nutritional, and microbial factors predict symptom improvement when following the low FODMAP and traditional IBS diet. Findings may help individualize dietary treatment in IBS.
-
4.
Igg Food Antibody Guided Elimination-Rotation Diet Was More Effective than FODMAP Diet and Control Diet in the Treatment of Women with Mixed IBS-Results from an Open Label Study.
Ostrowska, L, Wasiluk, D, Lieners, CFJ, Gałęcka, M, Bartnicka, A, Tveiten, D
Journal of clinical medicine. 2021;10(19)
-
-
-
-
Free full text
Plain language summary
IBS, also known as irritable bowel syndrome, is a debilitating condition characterised by abdominal pain, irregular bowel movements, and changes in the consistency of stool. Symptoms of IBS may appear shortly after eating a meal. Excluding foods high in FODMAP carbohydrates, such as fermentable oligo- and di-saccharides, mono- and disaccharides, and polyols, or following an elimination rotation diet to reduce IgG-dependent food hypersensitivity, which has been shown to improve IBS symptoms previously. The purpose of this open-label study is to investigate the effectiveness of a low-FODMAPS diet and an elimination rotation diet based on IgG as well as a control diet in reducing symptoms of IBS. During the eight-week study, 73 female subjects with a mix of IBS were assigned to either of the three dietary treatments. Compared to the other diet groups, the IgG based elimination rotation diet group showed a significant improvement in the IBS symptoms and comorbid symptoms after the intervention period. In order to determine whether IgG-mediated food hypersensitivity plays a role in IBS and the efficacy of an IgG-dependent elimination rotation diet in the general population, further robust research is required. Healthcare professionals, however, can make use of these results to gain a better understanding of how an IgG based elimination diet tailored to each individual can improve IBS symptoms.
Expert Review
Conflicts of interest:
None
Take Home Message:
- After implementing the three diets, among patients with IBS-M, a statistically significant reduction of the frequency of the idiopathic abdominal pain, abdominal pain after a meal, abdominal pain during defecation, and sensation of incomplete defecation before and after the diet plans, were only found in Group 2.
- Significantly, only in the Group 2 IgG based elimination-rotation-diet was there a high decrease or complete disappearance of dyspeptic IBS symptoms and co-morbidities together with IBS symptoms.
- This study shows that a personalised dietary approach is more effective in treating IBS than generalised diet recommendations, with elimination diets focused on IgG antibodies providing the best results.
Evidence Category:
-
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
-
B: Systematic reviews including RCTs of limited number
-
X
C: Non-randomized trials, observational studies, narrative reviews
-
D: Case-reports, evidence-based clinical findings
-
E: Opinion piece, other
Summary Review:
Science supports the use of a low-FODMAP diet for symptom relief of IBS. However, more recently evidence suggests that IBS is a low-grade inflammatory disease that may result from or lead to IgG-dependent food hyper-sensitivities.
This study compared the effectiveness of three dietary treatment plans in 73 female patients diagnosed with mixed-form IBS based on Rome III criteria and no other gastrointestinal condition over 8 weeks.
The 3 dietary groups were:
- Group 1-low FODMAP diet
- Group 2- IgG based elimination-rotation-diet
- Group 3-control diet (control group)
Diets of G1 and G2 were determined individually by a dietitian, based on low-FODMAP dietary information and results from IgG food sensitivity testing respectively. Group 3 received nutrition advice from a gastroenterologist.
In G1, some of the IBS symptoms significantly improved (mucus in stool, p = 0.031; bloating, p < 0.001). Gurgling sensation and gastric fullness also reach statistical significance in G1.
IBS symptoms as well as co-morbid symptoms significantly improved or disappeared completely in G2 (idiopathic abdominal pain, p < 0.001; abdominal pain after a meal, p < 0.001; abdominal pain during defecation, p = 0.008; sensation of incomplete defecation p = 0.001; difficulty to defecate (constipation) p = 0.002; bloating p = < 0.001; gurgling sensation < 0.001; gastric fullness p = < 0.001. However, blood and mucus in the stool were impossible to test because the symptoms were not reported by any patient during the 2nd examination). (p-values less than 0.05 were considered statistically significant).
In group G3 no statistically significant improvements were seen in any measure.
Based on the results of this open-label study, it was concluded that personalised dietary interventions were more effective in the treatment of IBS-M patients than generalised diet recommendations. Dietary elimination based on IgG food sensitivity test results had the greatest impact on IBS and related symptoms.This study supports results from other studies showing an IgG-guided diet as an effective strategy in co-morbid conditions such as fatigue, headache/migraine, and skin conditions.
Conflicts of Interest
C.F.J.L., M.G. and A.B. are employees of the Institute of Microecology in Poznan ,where the ImuPro tests were determined. D.T. is the Head of Laboratory and shareholder of Lab1, offering ImuPro tests in Norway.
Clinical practice applications:
- Low FODMAP diets studies (NICE) showed GI improvements for abdominal pain, abdominal cramps, diarrhoea, gas, and bloating, largely because FODMAPs mainly cause an excessive production of gas, leading to discomfort and pain and an increased osmotic effect leading to increased bowel movement and diarrhoea. However 30% of patients still suffered from bloating on the FODMAP diet. Gurgling sensation decreased from 65% to 15%, and gastric fullness decreased from 58% to 11% in the patients on the low FODMAP diet.
- A potential new approach to resolve functional symptoms of gastrointestinal conditions could be to start with an IgG-guided elimination diet, as it was proven to be the more effective diet in this open study, and in cases of persistent symptoms, it could be combined with a low-FODMAP diet.
- Calprotectin is currently one of the best-known diagnostic markers indicating mucosa inflammation and changes in the inflammation intensity. In this study serious intestinal inflammation was diagnosed at the faecal calprotectin concentration of >50 mg/kg of stool. During the first examination, no statistically significant differences were found in calprotectin concentrations between the compared groups of patients, and the values were low, suggesting that the included patients suffered from low-grade inflammation and were suitable for diet alteration as the best choice of treatment.
Limitations:
- The main limitations of this study are the open-labeled nature, the low number of participants and the bias of only including female participants with only the patients in the G2 group tested for IgG food antibodies.
- Foods consumed by the patients before they entered the study were not ascertained.
Considerations for future research:
- Claims that IgG food antibodies only reveal exposure to food and not intolerance should be reinvestigated in larger double-blinded studies.
Abstract
Irritable bowel syndrome (IBS) is a chronic disease with recurrent abdominal pain, disturbed bowel emptying, and changes in stool consistency. We compared the effectiveness of three different dietary treatment plans (G1-FM-low FODMAP diet, G2-IP IgG based elimination-rotation-diet, and as control group, the G3-K control diet recommended by an attending gastroenterologist) in treating patients diagnosed with mixed irritable bowel syndrome. A total of seventy-three female patients diagnosed with a mixed form of irritable bowel syndrome (IBS-M) were enrolled in the study. The diet of each patient in Group 1 (G1-FM) and 2 (G2-IP) was determined individually during a meeting with a dietitian. Patients from Group 3 (G3-K) received nutrition advice from a gastroenterologist. Significant differences in the reduction of IBS symptoms were found between the groups. IBS symptoms as well as comorbid symptoms significantly improved or disappeared completely in the G2-IP group (idiopathic abdominal pain, p < 0.001; abdominal pain after a meal, p < 0.001; abdominal pain during defecation, p = 0.008), while in the G1-FM group, some of the IBS symptoms significantly improved (mucus in stool, p = 0.031; bloating, p < 0.001). In group G3-K no significant improvement was seen. Based on the results of this open-label study, it was concluded that various dietary interventions in the treatment of IBS-M patients do not uniformly affect the course and outcomes of disease management. Rotation diets based on IgG show significantly better results compared to other diets.
-
5.
Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study).
Zhang, Y, Gu, Y, Ren, H, Wang, S, Zhong, H, Zhao, X, Ma, J, Gu, X, Xue, Y, Huang, S, et al
Nature communications. 2020;11(1):5015
-
-
-
-
Free full text
Plain language summary
Berberine, which is a naturally occurring alkaloid found in plants, has been traditionally used as a remedy to protect against Type 2 diabetes and other metabolic disorders. It is important to study how berberine affects the human gut microbiome, specifically in regard to its impact on short-chain fatty acid and bile acid metabolism, due to its low oral bioavailability. The PREMOTE study investigated the glycaemic lowering effects of individual and combination of berberine and probiotics in newly diagnosed Type 2 Diabetes patients. This randomised, double-blinded, placebo-controlled trial included four hundred and nine Type 2 diabetic patients and randomly assigned them (1:1:1:1 ratio) to receive berberine alone, berberine combined with probiotics, probiotics alone or a placebo for twelve weeks. A combination of berberine plus probiotics and berberine alone significantly improved glycated haemoglobin levels compared to the placebo and probiotics alone treatment. The antidiabetic effects of berberine could be due to the Ruminococcus bromii abundance followed by the berberine treatment and its ability to inhibit deoxycholic acid biotransformation. Further robust studies are required to consider the therapeutic application of berberine and probiotics in a general population due to the limitations of the present study. However, healthcare professionals can use the results of this trial to understand the mechanism behind the anti-diabetic effects of berberine and probiotics.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The use of berberine, as a specific antimicrobial agent, along with high strength probiotics may be beneficial for managing blood glucose and potentially other metabolic health markers alongside diet and lifestyle modifications
Evidence Category:
-
X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
-
B: Systematic reviews including RCTs of limited number
-
C: Non-randomized trials, observational studies, narrative reviews
-
D: Case-reports, evidence-based clinical findings
-
E: Opinion piece, other
Summary Review:
Introduction
Dysbiosis of the human gut microbiome has been associated with the development of type 2 diabetes (T2D). Research has found that, in part, mechanisms of action for the antidiabetic medications, Metformin and Acarbose, include alterations in the gut microbiome as well as the inhibition of bile acid (BA) metabolism and signalling. Remedies targeting the gut microbiota for treatment of T2D and other metabolic diseases have therefore been investigated.
Berberine (BBR) has been used in Indian Ayurvedic and Traditional Chinese Medicine to treat metabolic conditions for hundreds of years. Probiotics have also been extensively researched for their potential metabolic benefits. This randomised, double-blind, placebo-controlled trial aimed to investigate whether BBR and probiotics may be effective in managing T2D.
Methods
A total of 409 participants aged 42-61 years were recruited from 20 medical centres in China. All patients were newly diagnosed (<12 months) with T2D and had no previous antidiabetic medication history. Participants were randomised into 4 groups; Probiotics and BBR, BBR only, probiotics only or a placebo for 12 weeks. Subgroup analysis was also completed for those aged >50 and >54.
Dosage of BBR was 0.6 g prior to a meal, twice daily. 4 g of powdered multi-strain probiotics including 9 strains of lactic acid bacteria were taken at bedtime. All participants were given a 7-day broad-spectrum antibiotic treatment immediately prior to baseline. 391 people completed the trial. The primary outcome measurement was glycaemic haemoglobin (HbA1c). Secondary evaluations of additional metabolic markers included fasting and post-load plasma glucose (FPG, PPG), homeostasis assessment model index for insulin resistance (HOMA-IR), total cholesterol (TC), high density lipoprotein cholesterol (HDL-c), low density lipoprotein cholesterol (LDL-c) and serum triglycerides (TG).
Results
Results showed a reduction in glycaemic haemoglobin (HbA1c) for both the BBR plus probiotics group (least squares mean [95% CI] -1.04 [-1-19, -0.89]% ) and the BBR only group (-.99 [-1.16, 0.83]%). The results for these groups were significantly greater than the probiotics alone (-0.53 {-068, -0.37]%) and the placebo groups (0.59 [-0.75, -0.44]%).
Secondary metabolic evaluations for FPG and PPG, TC, LDL -c and TGs also showed similar improvements in the BBR and BBR plus probiotic groups only. Additionally, in the >50 and >54 subgroups BBR and probiotics marginally improved the HOMA-IR.
Metagenomic and metabolomic analysis of the gut microbiome was also undertaken after a one-week pre-treatment with antibiotics immediately prior to the trial and at week 13. These results showed that the blood glucose lowering effects of BBR may be due to decreased deoxycholic acid species (DCA) biotransformation by ruminococcus bromii.
Higher levels of adverse gastrointestinal side effects were reported in the BBR treatment groups, however, the authors reported that this did not affect glycemic control outcomes.
Conclusion
This study found that BBR had an antidiabetic effect through microbial alterations in the human gut microbiome
The authors declare no conflicts of interest.
Clinical practice applications:
- 600mg of BBR twice daily prior to a meal plus a multi-strain (lactic acid) probiotic of >50 billion colony forming units (CFU) for 12 weeks may be effective in lowering HbA1c in T2D clients diagnosed within the previous 12 months
- Further research is needed for clients with longer term T2D diagnosis
- Insulin resistance may be marginally improved in clients >50
- Practitioners should be aware that in this study, adverse gastrointestinal side effects were more likely to be be experienced with the use of BBR
Considerations for future research:
The authors reported several limitations to this study:
- A population of Chinese people living in China may not be generalisable to other ethnic/racial populations
- The study was over a short duration. Longer studies are needed to confirm the results
- Participants had newly diagnosed T2D and had not received any previous medications. Future studies should include patients with a longer diagnosis time
- Records should be kept of any additional lifestyle changes made by the participants
- Adverse reactions were experienced in the BBR groups, in this study. It was reported that the gut microbiome and anti-diabetic effects were not affected, however, this may be something to be considered in longer trials.
Abstract
Human gut microbiome is a promising target for managing type 2 diabetes (T2D). Measures altering gut microbiota like oral intake of probiotics or berberine (BBR), a bacteriostatic agent, merit metabolic homoeostasis. We hence conducted a randomized, double-blind, placebo-controlled trial with newly diagnosed T2D patients from 20 centres in China. Four-hundred-nine eligible participants were enroled, randomly assigned (1:1:1:1) and completed a 12-week treatment of either BBR-alone, probiotics+BBR, probiotics-alone, or placebo, after a one-week run-in of gentamycin pretreatment. The changes in glycated haemoglobin, as the primary outcome, in the probiotics+BBR (least-squares mean [95% CI], -1.04[-1.19, -0.89]%) and BBR-alone group (-0.99[-1.16, -0.83]%) were significantly greater than that in the placebo and probiotics-alone groups (-0.59[-0.75, -0.44]%, -0.53[-0.68, -0.37]%, P < 0.001). BBR treatment induced more gastrointestinal side effects. Further metagenomics and metabolomic studies found that the hypoglycaemic effect of BBR is mediated by the inhibition of DCA biotransformation by Ruminococcus bromii. Therefore, our study reports a human microbial related mechanism underlying the antidiabetic effect of BBR on T2D. (Clinicaltrial.gov Identifier: NCT02861261).