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Association between COVID-19 and Male Fertility: Systematic Review and Meta-Analysis of Observational Studies.
Wang, S, Zhang, A, Pan, Y, Liu, L, Niu, S, Zhang, F, Liu, X
The world journal of men's health. 2023;41(2):311-329
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Several studies have been published documenting possible relationships between Covid-19 and male infertility, but it remains unclear whether Covid-19 affects sperm quality and sex hormones. This meta-analysis and systematic review of observational studies aimed to determine any relationship between Covid-19 infection and male fertility. The results showed that Covid-19 decreased sperm count, sperm concentration, motility, but had no effect on semen volume, immotility, normal morphology or nonprogressive sperm motility. Infection also affected some hormone levels and that effects on hormones were dependent on age of infection onset. Covid-19 infection with or without fever also differentially affected outcomes with those with fever having reduced sperm concentration and progressive sperm motility, which was not seen in those who did not experience fever. Disease severity also affected outcomes with those with moderate Covid-19 having reduced sperm motility, which was not seen in individuals who had mild disease. It was concluded that Covid-19 infection reduced sperm quality and disrupted sex hormones. This study could be used by healthcare professionals to understand that Covid-19 infection may affect the fertility of men.
Abstract
PURPOSE Whether COVID-19 reduces male fertility remains requires further investigation. This meta-analysis and systematic review evaluated the impact of COVID-19 on male fertility. MATERIALS AND METHODS The literature in PubMed, Embase, MEDLINE, Web of Science, and Cochrane Library up to January 01, 2022 was systematically searched, and a meta-analysis was conducted to investigate the effect of COVID-19 on male fertility. Totally 17 studies with a total of 1,627 patients and 1,535 control subjects were included in our meta-analysis. RESULTS Regarding sperm quality, COVID-19 decreased the total sperm count (p=0.012), sperm concentration (p=0.001), total motility (p=0.001), progressive sperm motility (p=0.048), and viability (p=0.031). Subgroup analyses showed that different control group populations did not change the results. It was found that during the illness stage of COVID-19, semen volume decreased, and during the recovery stage of COVID-19, sperm concentration and total motility decreased <90 days. We found that sperm concentration and total motility decreased during recovery for ≥90 days. Fever because of COVID-19 significantly reduced sperm concentration and progressive sperm motility, and COVID-19 without fever ≥90 days, the sperm total motility and progressive sperm motility decreased. Regarding disease severity, the moderate type of COVID-19 significantly reduced sperm total motility, but not the mild type. Regarding sex hormones, COVID-19 increased prolactin and estradiol. Subgroup analyses showed that during the illness stage, COVID-19 decreased testosterone (T) levels and increased luteinizing hormone levels. A potential publication bias may have existed in our meta-analysis. CONCLUSIONS COVID-19 in men significantly reduced sperm quality and caused sex hormone disruption. COVID-19 had long-term effects on sperm quality, especially on sperm concentration and total motility. It is critical to conduct larger multicenter studies to determine the consequences of COVID-19 on male fertility.
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Age-Dependent Relationships Between Disease Risk and Testosterone Levels: Relevance to COVID-19 Disease.
Muehlenbein, M, Gassen, J, Nowak, T, Henderson, A, Morris, B, Weaver, S, Baker, E
American journal of men's health. 2023;17(2):15579883221130195
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A growing body of research finds that in men, testosterone levels may be prognostic of clinical outcomes related to coronavirus disease 2019 (COVID-19 disease). The presence of pre-existing chronic conditions in many patients with COVID-19 disease further complicates the relationship among testosterone and severe outcomes. The aim of this study was to examine whether pre-existing conditions for severe COVID-19 disease were related to serum-free testosterone levels in men who had not been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. This study obtained data from men (n = 142) who participated in the longitudinal study Waco COVID Survey. All data included in the study was collected as part of the initial intake survey and first laboratory appointment. Results show that serum-free testosterone levels decreased as a function of age. In fact, greater burden of pre-existing conditions for severe COVID-19 disease was related to lower testosterone levels among men younger than 40 years of age. Furthermore, in men older than 40 years of age the decrease in testosterone that accompanies aging attenuated the effect of the clinical risk score on free testosterone levels. Authors conclude that their findings add important insights into the complex role of androgens in chronic and infectious diseases and contribute to the growing body of literature on the relationship between chronic disease and men’s testosterone levels.
Abstract
Testosterone levels in men appear to be prognostic of a number of disease outcomes, including severe COVID-19 disease. Testosterone levels naturally decline with age and are lower in individuals with a number of comorbidities and chronic conditions. Low testosterone may therefore be both a cause and a consequence of illness, including COVID-19 disease. The present project examines whether preexisting conditions for severe COVID-19 disease were themselves related to serum-free testosterone levels in men who had not been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. A clinical risk score for severe COVID-19 disease was computed based on the results of previously published meta-analyses and cohort studies, and relationships between this score and testosterone levels were tested in 142 men ages 19 to 82 years. Greater burden of preexisting conditions for severe COVID-19 disease was related to lower testosterone levels among men younger than 40 years of age. In older men, the decrease in testosterone that accompanies aging attenuated the effect of the clinical risk score on free testosterone levels. Given that older age itself is a predictor of COVID-19 disease severity, these results together suggest that the presence of preexisting conditions may confound the relationship between testosterone levels and COVID-19 disease outcomes in men. Future research examining relationships among testosterone and outcomes related to infectious and chronic diseases should consider potential confounds, such as the role of preexisting conditions.
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Effects of mild/asymptomatic COVID-19 on semen parameters and sex-related hormone levels in men: a systematic review and meta-analysis.
Che, BW, Chen, P, Yu, Y, Li, W, Huang, T, Zhang, WJ, Xu, SH, He, J, Liu, M, Tang, KF
Asian journal of andrology. 2023;25(3):382-388
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Various studies have shown that coronavirus disease 2019 (COVID-19) can cause more harm and a higher mortality rate to men. However, the literature does not clearly show that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can cause serious and lasting damage to male reproductive function. The aims of this study were to explore the effects of mild/asymptomatic COVID-19 on semen parameters and sex-related hormone levels and to analyse the relationship between semen parameter values and semen collection time after infection, fever, and severity of COVID-19. This study is a systematic review and meta-analysis of thirteen studies of which only five were included in the meta-analysis. Results show that COVID-19 has a certain effect on male reproductive function in the short term especially within about 70 days after infection. Additionally, fever after infection only had a significant effect on sperm concentration. Authors conclude by recommending the avoidance of pregnancy for a short period of time when the male partner has been infected with COVID-19.
Abstract
Coronavirus disease 2019 (COVID-19) has yet to be proven to alter male reproductive function, particularly in the majority of mild/asymptomatic patients. The purpose of this study was to explore whether mild/asymptomatic COVID-19 affects semen quality and sex-related hormone levels. To find suitable comparative studies, a systematic review and meta-analysis was done up to January 22, 2022, by using multiple databases (Web of Science, PubMed, and Embase). Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to identify and choose the studies. Meta-analysis was used to examine the semen parameters and sex-related hormones of mild/asymptomatic COVID-19 patients before and after infection. The effects of semen collection time, fever, and intensity of verification on semen following infection were also investigated. A total of 13 studies (n = 770) were included in the analysis, including three case-control studies, six pre-post studies, and four single-arm studies. A meta-analysis of five pre-post studies showed that after infection with COVID-19, sperm concentration (I2 = 0; P = 0.003), total sperm count (I2 = 46.3%; P = 0.043), progressive motility (I2 = 50.0%; P < 0.001), total sperm motility (I2 = 76.1%; P = 0.047), and normal sperm morphology (I2 = 0; P = 0.001) decreased. Simultaneously, a systematic review of 13 studies found a significant relationship between semen collection time after infection, inflammation severity, and semen parameter values, with fever having only bearing on semen concentration. Furthermore, there was no significant difference in sex-related hormone levels before and after infection in mild/asymptomatic patients. Mild/asymptomatic COVID-19 infection had a significant effect on semen quality in the short term. It is recommended to avoid initiating a pregnancy during this period of time.
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Effects of Whole-Body Stretching Exercise during Lunch Break for Reducing Musculoskeletal Pain and Physical Exertion among Healthcare Professionals.
Alqhtani, RS, Ahmed, H, Alshahrani, A, Khan, AR, Khan, A
Medicina (Kaunas, Lithuania). 2023;59(5)
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The occurrence of muscle pain in healthcare workers has been attributed to the conditions within which they are working, mainly the load and physical effort that accompanies handling patients and prolonged awkward working postures. Back, neck, shoulder and hand pain have all been reported. Treatments have been extensively studied; however, few provide long-term benefits. Strength exercise and stretching during work hours has been proposed as a therapy and this randomised control trial of 60 healthcare professionals aimed to determine the effect of whole-body stretching (WBS) during rest breaks at work. The results showed that pain in the lower back, neck and knee were most reported by healthcare professions. By attending three 30-minute stretching exercise classes per week participants experienced less muscle pain and used less effort when performing a variety of job associated tasks. It was concluded that stretching during work time may improve feelings of muscle pain in healthcare professionals, however more large-scale research is warranted to confirm these findings. This study could be used by healthcare professionals to recommend stretching exercise to other healthcare workers and to those who perform manual jobs.
Abstract
Background and Objectives: To investigate the effect of whole-body stretching (WBS) exercise during lunch break for reducing musculoskeletal pain and physical exertion among healthcare professionals. Methods: Full-time healthcare professionals working in hospitals with more than one year of experience were invited to participate. Sixty healthcare professionals (age 37.15 ± 3.9 Years, height 1.61 ± 0.04 m, body mass 67.8 ± 6.3 kg, and BMI 26.5 ± 2.1 kg/m2) participated in this single-blinded, two-arm randomized controlled trial (RCT). Participants were divided into WBS (n = 30) and control (n = 30) groups. The WBS group performed a range of stretching exercises targeting the entire body during a lunch break period for 3 times a week for 6 weeks. The control group received an education program. Musculoskeletal pain and physical exertion were assessed using the Nordic musculoskeletal questionnaire and Borg rating of perceived exertion scale, respectively. Results: The 12-month prevalence of musculoskeletal discomfort among all healthcare professionals was highest in the low back region (46.7%), followed by the neck (43.3%), and then the knee (28.3%). About 22% of participants said that their neck discomfort impacted their job, while about 18% reported that their low back pain impacted their job. Results indicate that the WBS and education program had a beneficial impact on pain and physical exertion (p < 0.001). When comparing the two groups, the WBS group experienced a significantly greater decrease in pain intensity (mean difference 3.6 vs. 2.5) and physical exertion (mean difference 5.6 vs. 4.0) compared to an education program only. Conclusions: This study suggests that doing WBS exercises during lunchtime can help lessen musculoskeletal pain and fatigue, making it easier to get through the workday.
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The effects of Bacillus coagulans MTCC 5856 on functional gas and bloating in adults: A randomized, double-blind, placebo-controlled study.
Majeed, M, Nagabhushanam, K, Paulose, S, Arumugam, S, Mundkur, L
Medicine. 2023;102(9):e33109
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The reasons for bloating and feelings of stomach discomfort are not fully understood and it is thought that they may be caused by several factors. Amongst these is the possibility that small intestinal bacterial overgrowth (SIBO) and gut microbiota alterations play a role in the development of bloating. Many therapies exist for the symptomatic relief of bloating, however probiotics may be effective for the relief of bloating due to the role of gut microbiota in its development. This randomised control trial of 66 individuals with abdominal bloating, discomfort, and gas aimed to determine the effectiveness of a gut bacteria strain known as Bacillus coagulans MTCC 5856 on feelings of gas and bloating. The results showed that supplementation with B. coagulans MTCC 5856 for 4 weeks relieved feelings of bloating, burping, and gas. It was concluded that B. coagulans MTCC 5856 supplementation was effective at relieving gas and bloating and may be a safe approach for individuals who experience these symptoms. This study could be used by healthcare professionals to recommend B. coagulans MTCC 5856 as a safe and effective therapy for individuals who suffer from gastrointestinal problems such as gas, bloating and stomach discomfort.
Abstract
BACKGROUND Gut microbiome dysbiosis is a major cause of abdominal gas, bloating, and distension. Bacillus coagulans MTCC 5856 (LactoSpore) is a spore-forming, thermostable, lactic acid-producing probiotic that has numerous health benefits. We evaluated the effect of Lacto Spore on improving the clinical symptoms of functional gas and bloating in healthy adults. METHODS Multicenter, randomized, double-blind, placebo-controlled study at hospitals in southern India. Seventy adults with functional gas and bloating with a gastrointestinal symptom rating scale (GSRS) indigestion score ≥ 5 were randomized to receive B coagulans MTCC 5856 (2 billion spores/day, N = 35) or placebo (N = 35) for 4 weeks. Changes in the GSRS-Indigestion subscale score for gas and bloating and global evaluation of patient's scores from screening to the final visit were the primary outcomes. The secondary outcomes were Bristol stool analysis, brain fog questionnaire, changes in other GSRS subscales, and safety. RESULTS Two participants from each group withdrew from the study and 66 participants (n = 33 in each group) completed the study. The GSRS indigestion scores changed significantly (P < .001) in the probiotic group (8.91-3.06; P < .001) compared to the placebo (9.42-8.43; P = .11). The median global evaluation of patient's scores was significantly better (P < .001) in the probiotic group (3.0-9.0) than in the placebo group (3.0-4.0) at the end of the study. The cumulative GSRS score, excluding the indigestion subscale, decreased from 27.82 to 4.42% (P < .001) in the probiotic group and 29.12 to 19.33% (P < .001) in the placebo group. The Bristol stool type improved to normal in both the groups. No adverse events or significant changes were observed in clinical parameters throughout the trial period. CONCLUSIONS Bacillus coagulans MTCC 5856 may be a potential supplement to reduce gastrointestinal symptoms in adults with abdominal gas and distension.
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Effect of supplementation with probiotics or synbiotics on cardiovascular risk factors in patients with metabolic syndrome: a systematic review and meta-analysis of randomized clinical trials.
Chen, T, Wang, J, Liu, Z, Gao, F
Frontiers in endocrinology. 2023;14:1282699
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Metabolic syndrome (metS) is characterised by insulin resistance, dyslipidaemia, central obesity and/or high blood pressure and is a significant risk factor for cardiovascular disease and type 2 diabetes mellitus. MetS is associated with an imbalanced microbiome and some but not all studies have shown benefits of supplementation with probiotics. The aim of this systematic review and meta-analysis of randomised controlled trials was to evaluate the effects of pro- or synbiotics on cardiovascular risk factors (body mass index, LDL cholesterol, fasting blood glucose and systolic blood pressure) in patients with metS. 11 studies were included in the review of which 7 were judged to have a low risk of bias, whilst risk of bias was unclear in 4 articles. The meta-analysis found that pro- or synbiotics have a positive effect on body mass index, LDL cholesterol and fasting blood glucose but not on systolic blood pressure. Subgroup analysis of pro- and synbiotics separately also found no effects on systolic blood pressure.
Abstract
PURPOSE The effectiveness of probiotics or synbiotics in adults with metabolic syndromes (MetS) remains controversial, this meta-analysis will further analyze the effects of probiotics or synbiotics on cardiovascular factors in adults with MetS. METHODS We searched Web of Science, PubMed, Embase, Cochrane Library and other databases for randomized controlled trials (RCTs) on the effects of probiotics or synbiotics on MetS in adults up to July 2023, and used RevMan 5.4.0 software for statistical analysis. RESULTS This analysis included eleven RCTs (n = 608 participants), and the results showed that compared with the control group, supplementation with probiotics or synbiotics reduced body mass index (weighted mean difference, WMD = -0.83, 95% CI = [-1.21, -0.44], P <0.0001, n = 9), low-density lipoprotein (LDL-c) (standard mean difference, SMD = -0.24, 95% CI = [-0.41, -0.08], P = 0.004, n = 10), fasting blood glucose (FBG)(SMD = -0.17, 95% CI = [-0.33, -0.01], P = 0.03, n = 11), but had no beneficial effect on systolic blood pressure (SBP) (WMD = 1.24, 95% CI = [-2.06, 4.54], P = 0.46, n = 8) in MetS patients. CONCLUSION Supplementation with probiotics or synbiotics can reduce BMI, LDL-c, FBG in patients with MetS, but our findings did not demonstrate a favorable effect on reducing SBP. Future studies with larger samples and longer intervention periods are needed.
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Effects of prebiotics, probiotics and synbiotics on serum creatinine in non-dialysis patients: a meta-analysis of randomized controlled trials.
Liu, F, Liu, Y, Lv, X, Lun, H
Renal failure. 2023;45(1):2152693
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Creatinine is a biomarker of kidney function and is used to diagnose chronic kidney disease. The aim of this meta-analysis of randomised controlled trials was to evaluate the effect of supplementation with prebiotics, probiotics and synbiotics on serum creatinine levels in patients not receiving dialysis. 12 RCTs were included in the meta-analysis of which seven were judged to have a low risk of bias whilst 1 was judged to have a high risk of bias. Overall, there was no significant effect of supplementation on serum creatinine levels. The following three subgroup analyses also showed no significant effects on creatinine levels: 1) by probiotics, prebiotics and synbiotics separately; 2) by duration: two months or less or longer than two months, 3) subgroup of 7 studies which included patients with non-dialysis kidney disease. The authors concluded that probiotics, prebiotics and synbiotics do not decrease serum creatinine levels.
Abstract
OBJECTIVE Serum creatinine level are influenced by many factors. Although accumulated data suggested that prebiotics, probiotics and synbiotics supplements could affect serum creatinine level, the results remained controversial. The aim of the present paper was to evaluate the effects of prebiotics, probiotics and synbiotics on serum creatinine in non-dialysis patients. METHODS PubMed, EMBASE (Excerpta Medica Database) and the Cochrane Library databases were searched for eligible randomized, controlled trials (RCTs) which were limited to English language studies until 30 September 2022. A random-effects model was performed to analyze the impact of pooled trials. RESULT Twelve randomized, controlled trial studies were included in the meta-analysis. Prebiotics, probiotics or synbiotics supplementation did not significantly decrease the serum creatinine levels in non-dialysis patients compared to placebo [standardized mean difference (SMD) = 0.05; 95% confidence interval (CI): (-0.21, 0.31); p = 0.72; I2 = 61%]. CONCLUSION The present meta-analysis indicated that supplementation with prebiotics, probiotics and synbiotics could not act as promising adjuvant therapies to decrease the serum creatinine levels in non-dialysis patients.
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Defecation status, intestinal microbiota, and habitual diet are associated with the fecal bile acid composition: a cross-sectional study in community-dwelling young participants.
Saito, Y, Sagae, T
European journal of nutrition. 2023;62(5):2015-2026
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Primary bile acids (priBAs) are synthesised from cholesterol in the human liver, conjugated with either taurine or glycine [amino acids], and secreted into the intestinal tract, where they dissolve dietary lipids. Diet is a modifiable factor that can influence defecation status, BAs, and intestinal microbiota. The aim of this study was to identify associations among defecation status, intestinal microbiota, and diet by examining faecal BA composition in community-dwelling young participants. This study was a cross-sectional study which enrolled 70 students. Results showed that 20.9% of the participants had high faecal BA levels with predominantly priBAs. This cluster was associated with an increased relative abundance of Clostridium subcluster XIVa [bacteria], increased frequency of normal faeces, and decreased relative abundance of Bacteroides and Clostridium cluster IV [bacteria]. Conversely, high levels of cytotoxic [toxic to cells] secondary BA (secBA) were associated with low normal defecation frequency, low insoluble fibre intake, and high animal fat intake. Authors concluded that among community-dwelling young adults, secBA production is affected by both dietary and lifestyle related factors. Thus, their findings may inform novel strategies for preventing colorectal cancer and cholelithiasis.
Abstract
PURPOSE Bile acid (BA) metabolism by intestinal bacteria is associated with the risk of gastrointestinal diseases; additionally, its control has become a modern strategy for treating metabolic diseases. This cross-sectional study investigated the influence of defecation status, intestinal microbiota, and habitual diet on fecal BA composition in 67 community-dwelling young participants. METHODS Feces were collected for intestinal microbiota and BA analyses; data about defecation status and dietary habits were collected using the Bristol stool form scales and a brief-type self-administered diet history questionnaire, respectively. The participants were categorized into four clusters based on their fecal BA composition, according to cluster analysis, and tertiles based on deoxycholic acid (DCA) and lithocholic acid (LCA) levels. RESULTS The high primary BA (priBA) cluster with high fecal cholic acid (CA) and chenodeoxycholic acid (CDCA) levels had the highest frequency of normal feces, whereas the second BA (secBA) cluster with high levels of fecal DCA and LCA had the lowest. Alternately, the high-priBA cluster had a distinct intestinal microbiota, with higher Clostridium subcluster XIVa and lower Clostridium cluster IV and Bacteroides. The low-secBA cluster with low fecal DCA and LCA levels had the lowest animal fat intake. Nevertheless, the insoluble fiber intake of the high-priBA cluster was significantly higher than that of the high-secBA cluster. CONCLUSION High fecal CA and CDCA levels were associated with distinct intestinal microbiota. Conversely, high levels of cytotoxic DCA and LCA were associated with increased animal fat intake and decreased frequency of normal feces and insoluble fiber intake. CLINICAL TRIAL REGISTRY University Hospital Medical Information Network (UMIN) Center system (UMIN000045639); date of registration: 15/11/2019.
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Clinical Trial: Probiotics in Metformin Intolerant Patients with Type 2 Diabetes (ProGasMet).
Nabrdalik, K, Drożdż, K, Kwiendacz, H, Skonieczna-Żydecka, K, Łoniewski, I, Kaczmarczyk, M, Wijata, AM, Nalepa, J, Holleman, F, Nieuwdorp, M, et al
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2023;168:115650
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Metformin has been the number one drug of choice for the management of type 2 diabetes, however there is a proportion of individuals who suffer from stomach issues and discontinue therapy. This may be due to the possibility that metformin impacts gut microbiota composition. This randomised control trial of 82 individuals with metformin intolerance aimed to determine the effect of a multi-strain probiotic in conjunction with metformin administration. The results showed that whilst on probiotics, there was a significant improvement in symptoms, with reduced incidence and severity of nausea, reduced frequency and severity of stomach pain and bloating and self-assessed improvement of tolerability of metformin. Nausea was also decreased, but only when the probiotic was allowed time to act. It was concluded that probiotic supplementation improves gastrointestinal side effects associated with metformin intolerance. This study could be used by healthcare professionals to understand that individuals who are on metformin may experience gastrointestinal side effects, which may be relieved with a multi-strain probiotic.
Abstract
BACKGROUND For decades, metformin has been the drug of first choice in the management of type 2 diabetes. However, approximately 2-13% of patients do not tolerate metformin due to gastrointestinal (GI) side effects. Since metformin influences the gut microbiota, we hypothesized that a multi-strain probiotics supplementation would mitigate the gastrointestinal symptoms associated with metformin usage. METHODS AND ANALYSIS This randomized, double-blind, placebo-controlled, single-center, cross-over trial (ProGasMet study) assessed the efficacy of a multi-strain probiotic in 37 patients with metformin intolerance. Patients were randomly allocated (1:1) to receive probiotic (PRO-PLA) or placebo (PLA-PRO) at baseline and, after 12 weeks (period 1), they crossed-over to the other treatment arm (period 2). The primary outcome was the reduction of GI adverse events of metformin. RESULTS 37 out of 82 eligible patients were enrolled in the final analysis of whom 35 completed the 32 weeks study period and 2 patients resigned at visit 5. Regardless of the treatment arm allocation, while on probiotic supplementation, there was a significant reduction of incidence (for the probiotic period in PRO-PLA/PLA-PRO: P = 0.017/P = 0.054), quantity and severity of nausea (P = 0.016/P = 0.024), frequency (P = 0.009/P = 0.015) and severity (P = 0.019/P = 0.005) of abdominal bloating/pain as well as significant improvement in self-assessed tolerability of metformin (P < 0.01/P = 0.005). Moreover, there was significant reduction of incidence of diarrhea while on probiotic supplementation in PRO-PLA treatment arm (P = 0.036). CONCLUSION A multi-strain probiotic diminishes the incidence of gastrointestinal adverse effects in patients with type 2 diabetes and metformin intolerance.
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Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome.
Martoni, CJ, Srivastava, S, Damholt, A, Leyer, GJ
World journal of gastroenterology. 2023;29(28):4451-4465
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Probiotics are microorganisms that have been shown in previous research to improve symptoms of diarrhoea-predominant irritable bowel syndrome (IBS-D). This randomised control trial of 307 individuals with IBS-D aimed to determine the tolerability and efficacy of varying doses of the microbiota Lactiplantibacillus plantarum. The results showed that the severity of symptoms improved with L. plantarum regardless of whether individuals were given a high or low dose. Improvements were seen as soon as 28 days following supplementation. Abdominal pain severity, duration, bloating, bowel movements, and quality of life were all improved. Individuals in the study largely tolerated the supplement, with only a few occurrences of nausea and vomiting. It was concluded that L. plantarum is effective and safe for improving symptoms associated with IBS-D. This study could be used by healthcare professionals to recommend L. plantarum supplementation to individuals with hard to treat or persistent IBS-D.
Expert Review
Conflicts of interest:
None
Take Home Message:
- This randomised, double-blind, placebo controlled, multi-centre, parallel-arm and dose-ranging study showed that L. plantarum may be a strong candidate for the management of IBS-D symptoms and associated mental health effects.
- L. plantarum may be of particular benefit to individuals who are suffering from stress because of IBS-D.
- L. plantarum is well tolerated and may be of benefit to individuals who have ceased pharmaceutical treatments as a result of side-effects.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
This study aimed to determine the tolerability and efficacy of varying supplemental doses of Lactiplantibacillus plantarum (Lpla33) in adults with irritable bowel syndrome of the diarrhoea predominant subtype (IBS-D).
Methods
This randomised, double blind, placebo-controlled trial recruited 307 females and males aged 18-70 years with IBS-D based upon the Rome IV diagnostic criteria with Bristol Stool Scale stools of type 6 or 7.
Individuals were randomised to receive an eight-week intervention in one of three study groups: Group 1B: Lpla33 at 1 × 109 vs group 10B: 1x1010 colony forming units (CFU) per day vs placebo.
Results
- Improvement was seen in the primary outcome of IBS-D symptom severity (IBS-SSS) with both Lpla33 doses compared to placebo at the end of the trial (P=<0.001).
- Improvements with both doses compared to placebo were seen as quickly as 28 days (P=<0.01).
- At the end of the study the higher dose Lpla33 was more effective at improving IBS-SSS compared to the lower dose (P=<0.05).
- Improvements to IBS remission or mild IBS were seen in 48.1% in group 1B, 72.6% in group 10B and only 11.1% of placebo (P=<0.001).
- Specific improvements were seen in 10B group compared to placebo in abdominal pain severity and duration, abdominal distension, bowel habits, and quality of life (QoL) (P=<0.001).
- Post-hoc analysis showed that supplementation prevented symptom development compared to placebo with 2.9% of group 1B, 2.1% of group 10B and 18.2% of placebo individuals reporting increased symptom severity (P=<0.001).
- QoL and perceived stress were improved with supplementation compared to placebo (P=<0.001 for both), with the higher dose being more beneficial than the lower dose in QoL (P=<0.001).
- Compliance to Lpla33 was comparable to placebo (P=>0.05), with adverse events related to the supplement including nausea and vomiting.
Conclusion
- L. plantarum at doses of 1 × 109 and 1 × 1010 CFU/day is a well-tolerated and efficacious therapy for the improvement of symptoms related to IBS-D, with benefits seen as quickly as 28 days after commencing supplementation.
- Symptoms such as abdominal pain severity and duration, QoL and perceived stress may all be improved.
- Stool normalisation may be seen in certain individuals.
Clinical practice applications:
- L. plantarum supplementation may be of benefit to the management and improvement of symptoms in individuals with IBS-D.
- Improvements may be seen physically and in mental health parameters.
- Metronidazole (400mg/day) was given as a rescue medication for individuals with severe pain and frequent loose stools and should be considered when interpreting results.
Considerations for future research:
- The authors concluded that future research should focus on understanding the mechanisms of action that may be involved.
- Studying the role of diet on the microbial community and metabolite profiles in IBS-D may be of interest.
Abstract
BACKGROUND Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D); however, the certainty of evidence is low. Well-powered randomized controlled dose-ranging trials are warranted on promising single-strain candidates. AIM: To investigate the clinical efficacy of Lactiplantibacillus plantarum (L. plantarum) Lpla33 (DSM34428) in adults with IBS-D. METHODS This is a randomized, double-blind, placebo-controlled, multi-center, and dose-ranging study. Three hundred and seven adults, 18-70 years of age, with IBS-D, according to Rome IV criteria, were allocated (1:1:1) to receive placebo or L. plantarum Lpla33 at 1 × 109 (1B) or 1 × 1010 (10B) colony-forming units/d over an 8-wk intervention period. The primary outcome was the change in IBS severity scoring system (IBS-SSS) total score after 8 wk, while secondary and exploratory outcomes included abdominal pain severity, IBS related quality of life, stool and microbial profile, and perceived stress. RESULTS IBS-SSS was significantly reduced, after 8 wk, in participants receiving L. plantarum 1B (-128.45 ± 83.30; P < 0.001) and L. plantarum 10B (-156.77 ± 99.06; P < 0.001), compared to placebo (-58.82 ± 74.75). Further, a dose-ranging effect was observed, with a greater absolute reduction in the L. plantarum 10B group (P < 0.05). A reduction in sub-scores related to abdominal pain, abdominal distension, bowel habits, and quality of life was observed in both L. plantarum groups compared to placebo (P < 0.001). Further, 62.5% and 88.4% of participants administered L. plantarum 1B and 10B, respectively, were classified as stool consistency responders based on a reduction in diarrheal stool form, as compared to 26.3% in the placebo group (P < 0.001). In contrast, no significant shifts were observed in microbial diversity. CONCLUSION L. plantarum Lpla33 (DSM34428) is well tolerated and improves IBS symptom severity with a dose-ranging effect and a corresponding normalization of bowel habits in adults with IBS-D.