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Effects of galactooligosaccharides on maternal gut microbiota, glucose metabolism, lipid metabolism and inflammation in pregnancy: A randomized controlled pilot study.
Wan, J, An, L, Ren, Z, Wang, S, Yang, H, Ma, J
Frontiers in endocrinology. 2023;14:1034266
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During pregnancy, a disordered gut microbiome and abnormal glucose metabolism may be possible mechanisms for pregnancy complications such as gestational diabetes mellitus (GDM). Different from probiotics, galactooligosaccharides (GOS) is a prebiotic that is not digested and absorbed by the host, but can selectively promote the metabolism and proliferation of beneficial bacteria in the body, particularly Lactobacillus and Bifidobacterium. The aim of this study was to evaluate the feasibility, acceptability, and safety of prebiotic intervention in healthy pregnant women, and conduct a preliminary exploration of the possible benefits for pregnant women. This study was a prospective double-blinded randomised clinical trial involving pregnant women. Participants were randomly assigned to the control group and the intervention group at a 1:1 ratio. Results showed that GOS intervention had no significant effect on reducing the incidence of GDM and improving glucose and lipid metabolism. Furthermore, there was no significant difference in glucose and lipid metabolism levels between GOS group and placebo group. Authors conclude that GOS can be considered as a dietary supplement during pregnancy. However, further clinical studies are needed to strengthen the findings of this study.
Abstract
BACKGROUND Gut microbiota of pregnant women change with the gestational week. On the one hand, they participate in the metabolic adaptation of pregnant women. On the other hand, the abnormal composition of gut microbiota of pregnant women is more likely to suffer from gestational diabetes mellitus (GDM). Therefore, gut microbiota targeted treatment through dietary supplements is particularly important for prevention or treatment. Prebiotic supplements containing galactooligosaccharides (GOS) may be an intervention method, but the effect is still unclear. OBJECTIVE This study aims to evaluate the feasibility and acceptability of prebiotic intervention in healthy pregnant women during pregnancy, and to explore the possible effects of intervention on pregnant women and the influence on gut microbiota as preliminaries. METHODS After recruitment in first trimester, 52 pregnant women were randomly assigned to receive GOS intervention or placebo containing fructooligosaccharides. 16S rRNA sequencing technology was used to detect the composition, diversity and differential flora of gut microbiota. Lipid metabolism, glucose metabolism and inflammatory factors during pregnancy were also analyzed. RESULTS The adverse symptoms of GOS intervention are mild and relatively safe. For pregnant women, there was no significant difference in the GDM incidence rates and gestational weight gain (GWG) in the GOS group compared with placebo (P > 0.05). Compared with the placebo group, the levels of FPG, TG, TC, HDL-C LDL-C, and IL-6 had no significant difference in GOS group (P > 0.05). For newborns, there was no significant difference between GOS group and placebo group in the following variables including gestational week, birth weight, birth length, head circumference, chest circumference, sex, and delivery mode (P > 0.05). And compared with the placebo group, the GOS group had a higher abundance of Paraprevotella and Dorea, but lower abundance of LachnospiraceaeUCG_001. CONCLUSIONS GOS prebiotics appear to be safe and acceptable for the enrolled pregnancies. Although GOS intervention did not show the robust benefits on glucose and lipid metabolism. However, the intervention had a certain impact on the compostion of gut microbiota. GOS can be considered as a dietary supplement during pregnancy, and further clinical studies are needed to explore this in the future.
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The Impact of Synbiotic Treatment on the Levels of Gut-Derived Uremic Toxins, Inflammation, and Gut Microbiome of Chronic Kidney Disease Patients-A Randomized Trial.
Mitrović, M, Stanković-Popović, V, Tolinački, M, Golić, N, Soković Bajić, S, Veljović, K, Nastasijević, B, Soldatović, I, Svorcan, P, Dimković, N
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2023;33(2):278-288
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The gut microbiome consists of more than 100 trillion bacteria and plays an important role in normal body functioning. There is increasing evidence that gut microbiome alteration can affect multiple organ systems and also lead to numerous chronic diseases, such as chronic kidney disease (CKD). The aim of this study was to assess the efficacy and safety of synbiotic treatment in reducing the levels of gut-derived uremic toxins and serum inflammatory markers and its impact on gut microbiome, with controlled factors such as diet and antibiotic usage. This study was a single-centre, randomised, double-blind, placebo-controlled study. After a 2-week run-in period under prescribed diet, patients were randomised into 2 groups, one receiving synbiotic therapy and the other receiving placebo. Results showed that in comparison to placebo: - synbiotic treatment significantly altered levels of indoxyl sulfate [uremic toxin] and p-cresyl sulfate [uremic toxin] in the intervention arm, and - only the dynamic of total serum indoxyl sulfate was significant. Authors conclude that synbiotics are a safe and an effective therapeutic strategy that may help to decrease levels of uremic toxins and microinflammation in chronic kidney disease patients.
Abstract
OBJECTIVE Altering dysbiotic gut flora through synbiotic supplementation has recently been recognized as a potential treatment strategy to reduce the levels of gut-derived uremic toxins and decrease inflammation. Assessing its efficacy and safety has been the main goal of our randomized, double-blind, placebo-controlled study. METHODS A total of 34 nondialyzed chronic kidney disease patients, aged ≥18 years, with an estimated glomerular filtration rate between 15 and 45 mL/minute, were randomized either to an intervention group (n = 17), receiving synbiotic (Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium lactis, 32 billion colony forming units per day plus 3.2 g of inulin), or control group (n = 17), receiving placebo during 12 weeks. The impact of treatment on the dynamic of serum levels of gut-derived uremic toxins, total serum indoxyl sulfate, p-cresyl sulfate, and trimethylamine N-oxide, was defined as the primary outcome of the study. Secondary outcomes included changes in the stool microbiome, serum interleukin-6 levels, high-sensitivity C-reactive protein, estimated glomerular filtration rate, albuminuria, diet, gastrointestinal symptom dynamics, and safety. Serum levels of uremic toxins were determined using ultraperformance liquid chromatography. The stool microbiome analysis was performed using the 16S ribosomal ribonucleic acid gene sequencing approach. RESULTS Synbiotic treatment significantly modified gut microbiome with Bifidobacteria, Lactobacillus, and Subdoligranulum genera enrichment and consequently reduced serum level of indoxyl sulfate (ΔIS -21.5% vs. 5.3%, P < .001), improved estimated glomerular filtration rate (ΔeGFR 12% vs. 8%, P = .029), and decreased level of high-sensitivity C-reactive protein (-39.5 vs. -8.5%, P < .001) in treated patients. Two patients of the intervention arm complained of increased flatulence. No other safety issues were noted. CONCLUSION Synbiotics could be available, safe, and an effective therapeutic strategy we could use in daily practice in order to decrease levels of uremic toxins and microinflammation in chronic kidney disease patients.
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Ameliorating effects of L-carnitine and synbiotic co-supplementation on anthropometric measures and cardiometabolic traits in women with obesity: a randomized controlled clinical trial.
Fallah, F, Mahdavi, R
Frontiers in endocrinology. 2023;14:1237882
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Obesity is a multifactorial relapsing chronic disease attributed to the complicated interaction of behavioural, environmental, and genetic factors. Given the adverse effects of anti-obesity medications, there has been a great appeal in the consumption of weight loss supplements among individuals suffering from obesity seeking a “magic bullet,” which is less demanding than conventional weight management protocols. The aim of this study was to assess the effects of concomitant supplementation of L-carnitine and a multistrain/multispecies synbiotic compared with L-carnitine single therapy on the anthropometric and cardiometabolic indices in healthy women with obesity. This study was a double-blind, controlled, randomised clinical trial. Following a 2-week run-in period, the participants were randomly allocated to the “L-carnitine + synbiotic” or “L-carnitine + placebo” groups (1:1 ratio). Results showed that supplementation of multistrain/multispecies synbiotic (250 mg/day) concomitant with L-carnitine (2 × 500 mg/day) for 8 weeks led to greater amendments in anthropometric and glycaemic indices, and high-density lipoprotein cholesterol in healthy female individuals with obesity without any severe side effects. Authors concluded that co-administration of L-carnitine and synbiotic may be an encouraging therapeutic strategy for obesity and related cardiometabolic complications.
Abstract
BACKGROUND Obesity, a multifactorial disorder with pandemic dimensions, is conceded a major culprit of morbidity and mortality worldwide, necessitating efficient therapeutic strategies. Nutraceuticals and functional foods are considered promising adjuvant/complementary approaches for weight management in individuals with obesity who have low adherence to conventional treatments. Current literature supports the weight-reducing efficacy of pro/pre/synbiotics or L-carnitine; however, the superiority of the nutraceutical joint supplementation approach over common single therapies to counter obesity and accompanying comorbidities is well documented. This study was designed to assess the effects of L-carnitine single therapy compared with L-carnitine and multistrain/multispecies synbiotic co-supplementation on anthropometric and cardiometabolic indicators in women with obesity. METHODS The current placebo-controlled double-blind randomized clinical trial was performed on 46 women with obesity, randomly allocated to either concomitant supplementation [L-carnitine tartrate (2 × 500 mg/day) + multistrain/multispecies synbiotic (1 capsule/day)] or monotherapy [L-carnitine tartrate (2 × 500 mg/day) + maltodextrin (1 capsule/day)] groups for 8 weeks. Participants in both groups received healthy eating dietary advice. RESULTS Anthropometric, lipid, and glycemic indices significantly improved in both intervention groups; however, L-carnitine + synbiotic co-administration elicited a greater reduction in the anthropometric measures including body mass index (BMI), body weight, and neck, waist, and hip circumferences (p < 0.001, <0.001, <0.001, = 0.012, and =0.030, respectively) after adjusting for probable confounders. Moreover, L-carnitine + synbiotic joint supplementation resulted in a greater reduction in fasting blood sugar (FBS), insulin (though marginal), and homeostatic model assessment of insulin resistance (HOMA-IR) and more increment in quantitative insulin sensitivity check index (QUICKI; p = 0.014, 0.051, 0.024, and 0.019, respectively) compared with the L-carnitine + placebo monosupplementation. No significant intergroup changes were found for the lipid profile biomarkers, except for a greater increase in high-density lipoprotein-cholesterol concentrations (HDL-C) in the L-carnitine + synbiotic group (p = 0.009). CONCLUSION L-carnitine + synbiotic co-supplementation was more beneficial in ameliorating anthropometric indices as well as some cardiometabolic parameters compared with L-carnitine single therapy, suggesting that it is a promising adjuvant approach to ameliorate obesity or associated metabolic complications through potential synergistic or complementary mechanisms. Further longer duration clinical trials in a three-group design are demanded to verify the complementary or synergistic mechanisms. CLINICAL TRIAL REGISTRATION www.irct.ir, Iranian Registry of Clinical Trials IRCT20080904001197N13.
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Effects of inulin supplementation on body composition and metabolic outcomes in children with obesity.
Visuthranukul, C, Chamni, S, Kwanbunbumpen, T, Saengpanit, P, Chongpison, Y, Tepaamorndech, S, Panichsillaphakit, E, Uaariyapanichkul, J, Nonpat, N, Chomtho, S
Scientific reports. 2022;12(1):13014
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The prevalence of overweight and obesity among children and adolescents has risen dramatically. Overweight and obese children are at risk of developing co-morbidities such as type 2 diabetes mellitus, hypertension, dyslipidaemia, metabolic syndrome, non-alcohol fatty liver disease and premature cardiovascular diseases. Furthermore, obese children are highly prone to become obese adults. The aim of this study was to determine the effects of prebiotic (as inulin) supplementation on body weight, adiposity, and metabolic profiles in obese Thai children. This study is a randomised double-blinded placebo-controlled trial. Participants (n=165) were randomly allocated to 3 groups: inulin, placebo, and dietary fibre advice group. Results show that the intensive behavioural modification and frequent follow-up are effective strategies to reduce body mass index and adiposity in obese children. Furthermore, even though inulin supplementation did not demonstrate considerable effect on adiposity and metabolic outcomes, it can increase fat-free mass in these children. Authors conclude that further research regarding the change of gut microbiota composition and their metabolites are needed to determine inulin’s impact on host microbe interaction in obese paediatric population.
Abstract
Inulin might improve body composition in obese children. We aimed to determine the effects of inulin supplementation on body composition and metabolic outcomes in obese children. A randomized, double-blinded placebo-controlled study was conducted in obese Thai children aged 7-15 years. Participants were assigned to 3 treatment groups for 6 months: 13 g of extracted inulin powder from Thai Jerusalem artichoke, isocaloric maltodextrin, and dietary fiber advice groups. Body composition was assessed by bioelectrical impedance analysis. One-hundred and fifty-five children completed the study (mean age 10.4 ± 2.2 years, BMI z-score 3.2 ± 1.0, 59% male). The drop-out rate was 6%. The inulin extract yielded more than 90% compliance without significant gastrointestinal side effects. All three groups demonstrated a significant decrease in BMI z-score, fat mass index (FMI), and trunk FMI, but the differences between groups were not observed. Fat-free mass index significantly increased only in the inulin group (16.18 ± 1.90 vs. 16.38 ± 1.98 kg/m2, P = 0.009). There were no significant differences in the metabolic profiles between groups. Despite showing no substantial effect on adiposity, inulin may increase fat-free mass in obese children. Further research in the change of gut microbiota composition is needed to determine inulin's impact on host-microbe interaction in pediatric obesity.
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White common bean extract remodels the gut microbiota and ameliorates type 2 diabetes and its complications: A randomized double-blinded placebo-controlled trial.
Feng, Y, Zhu, J, Wang, Q, Cao, H, He, F, Guan, Y, Li, D, Yan, J, Yang, J, Xia, Y, et al
Frontiers in endocrinology. 2022;13:999715
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Patients with type 2 diabetes (T2D) have a higher risk of macrovascular complications. Intensive glycaemic control reduces microvascular complications and exerts a modest improved effect on macrovascular outcomes. The main aim of this study was to explore the effects of white common bean extract (WCBE) on glucose metabolism and diabetic complications in patients with T2D. This study was a randomised double-blind placebo-controlled trial which enrolled ninety-six patients with T2D aged between 35 and 75 years. Participants were randomly assigned in a 1:2 ratio to the control group and WCBE group. Results showed that WCBE alleviated glucose metabolism dysbiosis and diabetic complication indices. In fact, after 2 months of an intense intervention with a WCBE treatment and in the following two-month maintenance period, the improvements to glycaemic metabolism were preserved. Furthermore, there was notable improvement of the structure of the gut microbiota, especially the enrichment of short-chain fatty acid-producing bacteria and inhibition of opportunistic pathogens. Authors conclude that WCBE may be considered as a novel prebiotic antidiabetic agent for the regulation of glucose metabolism and gut microbiota homeostasis and may slightly ameliorate diabetic complications in patients with T2D.
Abstract
OBJECTIVE Excessive carbohydrate intake is a high risk factor for increased morbidity of type 2 diabetes (T2D). A novel regimen for the dietary care of diabetes that consists of a highly active α-amylase inhibitor derived from white common bean extract (WCBE) and sufficient carbohydrates intake was applied to attenuate T2D and its complications. Furthermore, the role of gut microbiota in this remission was also investigated. METHODS We conducted a 4-month randomized double-blinded placebo-controlled trial. During the intense intervention period, ninety subjects were randomly assigned to the control group (Group C) and WCBE group (Group W). Subjects in Group C were supplemented with 1.5 g of maltodextrin as a placebo. Subjects in Group W took 1.5 g of WCBE half an hour before a meal. Fifty-five participants continued the maintenance intervention receiving the previous dietary intervention whereas less frequent follow-up. The variation in biochemical, vasculopathy and neuropathy indicators and the structure of the fecal microbiota during the intervention was analyzed. RESULT Glucose metabolism and diabetic complications showed superior remission in Group W with a 0.721 ± 0.742% decline of glycosylated hemoglobin after 4 months. The proportion of patients with diabetic peripheral neuropathy (Toronto Clinical Scoring System, TCSS ≥ 6) was significantly lower in Group W than in Group C. Both the left and right sural sensory nerve conduction velocity (SNCV-left sural and SNCV-right sural) slightly decreased in Group C and slightly increased in Group W. Additionally, the abundances of Bifidobacterium, Faecalibacterium and Anaerostipes were higher in Group W, and the abundances of Weissella, Klebsiella, Cronobacter and Enterobacteriaceae_unclassified were lower than those in Group C at month 2. At the end of month 4, Bifidobacterium remained more abundant in Group W. CONCLUSION To our knowledge, this is the first report of improvement to diabetes complications by using a dietary supplement in such a short-term period. The enrichment of SCFA-producing bacteria might be responsible for the attenuation of T2D and its complications. CLINICAL TRIAL REGISTRATION NUMBER http://www.chictr.org.cn/edit.aspx?pid=23309&htm=4, identifier ChiCTR-IOR-17013656.
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Fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs), but not gluten, elicit modest symptoms of irritable bowel syndrome: a double-blind, placebo-controlled, randomized three-way crossover trial.
Nordin, E, Brunius, C, Landberg, R, Hellström, PM
The American journal of clinical nutrition. 2022;115(2):344-352
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Irritable bowel syndrome (IBS) is a chronic functional bowel disorder that is characterised by recurring abdominal pain over ≥3 months within a 6-month period in association with altered bowel habits. Symptomatic treatment of IBS includes dietary adaptation, with a focus on prebiotics, probiotics, gluten, and fermentable oligo-, di-, monosaccharides and polyols (FODMAPs). The main aim of this study was to investigate the effects of weeklong interventions with high intakes of a wide range of FODMAPs, gluten, or a nonfermentable placebo in subjects with moderate to severe IBS. This study is a double-blind, placebo-controlled, randomised 3-way study with triple crossover design. One-hundred and ten participants were enrolled and randomly assigned for the study. Results show that a mixture of widely consumed FODMAPs caused only modest worsening of gastrointestinal symptoms compared with gluten and placebo. Authors conclude that there were interindividual variability in the intervention responses. Thus, future studies should investigate these differences to understand possible underlying disease mechanisms.
Abstract
BACKGROUND Irritable bowel syndrome (IBS) has been associated with diets rich in fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs), and gluten. Most previous studies have been single-blind and have focused on the elimination of FODMAPs or provocation with single FODMAPs. The effect of gluten is unclear, large trials isolating the effect of gluten from that of FODMAPs are needed. OBJECTIVES The aims of this study were to ensure high intakes of a wide range of FODMAPs, gluten, or placebo, and to evaluate the effects on IBS symptoms using the IBS-severity scoring system (IBS-SSS). METHODS The study was carried out with a double-blind, placebo-controlled, randomized 3-way crossover design in a clinical facility in Uppsala from September 2018 to June 2019. In all, 110 participants fulfilling the IBS Rome IV criteria, with moderate to severe IBS, were randomly assigned; 103 (90 female, 13 male) completed the trial. Throughout, IBS participants maintained a diet with minimal FODMAP content and no gluten. Participants were block-randomly assigned to 1-wk interventions with FODMAPs (50 g/d), gluten (17.3 g/d), or placebo, separated by 1-wk washout. All participants who completed ≥1 intervention were included in the intention-to-treat analysis. RESULTS In participants with IBS (n = 103), FODMAPs caused higher IBS-SSS scores (mean 240 [95% CI: 222, 257]) than placebo (198 [180, 215]; P = 0.00056) or gluten (208 [190, 226]; P = 0.013); no differences were found between the placebo and gluten groups (P = 1.0). There were large interindividual differences in IBS-SSS scores associated with treatment. No adverse events were reported. CONCLUSION In participants with IBS, FODMAPs had a modest effect on typical IBS symptoms, whereas gluten had no effect. The large interindividual differences in responses to the interventions warrant further detailed studies to identify possible underlying causes and enable individual prediction of responses. This trial was registered at www.clinicaltrials.gov as NCT03653689.
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Multi-strain probiotics (Hexbio) containing MCP BCMC strains improved constipation and gut motility in Parkinson's disease: A randomised controlled trial.
Ibrahim, A, Ali, RAR, Manaf, MRA, Ahmad, N, Tajurruddin, FW, Qin, WZ, Desa, SHM, Ibrahim, NM
PloS one. 2020;15(12):e0244680
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Constipation is one of the commonest non-motor symptoms in Parkinson’s disease (PD). Recently, gut dysbiosis with alterations in faecal microbial composition was associated with the pathogenesis of PD and constipation. The aim of this study was to analyse the efficacy of a multi-strain probiotic combined with a prebiotic fibre (fructo-oligosaccharide) compared to placebo, on constipation symptoms and intestinal motility, in PD patients with constipation. This study is an eight-week investigator-initiated, double-blind, randomised, placebo-controlled single centre clinical trial involving 55 idiopathic PD patients. Patients were randomly assigned to one of the two treatment groups. Results showed that: - the consumption of a multi-strain probiotic (Hexbio) over 8 weeks, significantly improved bowel opening frequency and gut transit time in PD patients with constipation. - PD patients who consumed probiotics experienced a significantly higher mean weekly bowel movement compared to the placebo group. - patients who received probiotics reported increased weekly bowel opening frequency. - the percentage of patients who remained constipated was also significantly lower in the probiotic group (22.7%) compared to 57.7% in the placebo group. Authors conclude that Hexbio containing MCP BCMC strains was safe and effective in improving bowel opening frequency and gastrointestinal motility in PD patients with constipation.
Abstract
OBJECTIVE We determined the effectiveness of a multi-strain probiotic (Hexbio®) containing microbial cell preparation MCP®BCMC® on constipation symptoms and gut motility in PD patients with constipation. METHODS PD patients with constipation (ROME III criteria) were randomized to receive a multi-strain probiotic (Lactobacillus sp and Bifidobacterium sp at 30 X 109 CFU) with fructo-oligosaccaride or placebo (fermented milk) twice daily for 8 weeks. Primary outcomes were changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire (GQ), which included an item on bowel opening frequency. Secondary outcomes were gut transit time (GTT), quality of life (PDQ39-SI), motor (MDS-UPDRS) and non-motor symptoms (NMSS). RESULTS Of 55 recruited, 48 patients completed the study: 22 received probiotic and 26 received placebo. At 8 weeks, there was a significantly higher mean weekly BOF in the probiotic group compared to placebo [SD 4.18 (1.44) vs SD 2.81(1.06); (mean difference 1.37, 95% CI 0.68, 2.07, uncorrected p<0.001)]. Patients in the probiotic group reported five times higher odds (odds ratio = 5.48, 95% CI 1.57, 19.12, uncorrected p = 0.008) for having higher BOF (< 3 to 3-5 to >5 times/week) compared to the placebo group. The GTT in the probiotic group [77.32 (SD55.35) hours] reduced significantly compared to placebo [113.54 (SD 61.54) hours]; mean difference -36.22, 95% CI -68.90, -3.54, uncorrected p = 0.030). The mean change in GTT was 58.04 (SD59.04) hour vs 20.73 (SD60.48) hours respectively (mean difference 37.32, 95% CI 4.00, 70.63, uncorrected p = 0.028). No between-groups differences were observed in the NMSS, PDQ39-SI, MDS-UPDRS II and MDS-UPDRS III scores. Four patients in the probiotics group experienced mild reversible side effects. CONCLUSION This study showed that consumption of a multi-strain probiotic (Hexbio®) over 8 weeks improved bowel opening frequency and whole gut transit time in PD patients with constipation.