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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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Sodium Butyrate Effectiveness in Children and Adolescents with Newly Diagnosed Inflammatory Bowel Diseases-Randomized Placebo-Controlled Multicenter Trial.
Pietrzak, A, Banasiuk, M, Szczepanik, M, Borys-Iwanicka, A, Pytrus, T, Walkowiak, J, Banaszkiewicz, A
Nutrients. 2022;14(16)
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Inflammatory bowel diseases (IBD), such as Crohn’s Disease and ulcerative colitis, are chronic gastrointestinal disorders with periods of exacerbation and remission. The disease develops as a result of an abnormal immune response in the gastrointestinal mucosa in genetically predisposed individuals exposed to certain environmental conditions. The primary aim of this study was to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD. This study is a prospective, randomised, and placebo-controlled trial. Patients (n = 80) were randomised and assigned to one of two groups: group A received butyric acid at a dose of 150 mg, and group B received 150 mg placebo. Results show that supplementation with sodium butyrate to be ineffective in the add-on treatment of newly diagnosed children and adolescents with IBD. Furthermore, during the study, none of the participants reported adverse events. Authors conclude that the results of their study will contribute to further studies that will determine which patients with IBD may benefit from sodium butyrate supplementation. Further clinical trials on large groups of patients are needed to establish if IBD patients may benefit from sodium butyrate.
Abstract
BACKGROUND Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD. METHODS This was a prospective, randomized, placebo-controlled multicenter study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study. RESULTS In total, 72 patients with initially active disease completed the study, 29 patients in group A and 43 in group B. At week 12 of the study, the majority of patients achieved remission. No difference in remission rate or median disease activity was found between the two groups (p = 0.37 and 0.31, respectively). None of the patients reported adverse events. CONCLUSIONS A 12-week supplementation with sodium butyrate, as adjunctive therapy, did not show efficacy in newly diagnosed children and adolescents with IBD.