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The efficacy of a synbiotic containing Bacillus Coagulans in treatment of irritable bowel syndrome: a randomized placebo-controlled trial.

ABSTRACT: AIM:We aimed to evaluate the efficacy of a synbiotic containing Bacillus Coagulans in treatment of IBS. BACKGROUND:Some studies have shown the efficacy of probiotics in the treatment of irritable bowel syndrome (IBS). PATIENTS AND METHODS:Adult IBS patients (n=85) were randomized to receive a synbiotic containing Bacillus Coagulans or placebo for 12 weeks. Frequency of IBS symptoms including abdominal pain (scored 1 to 7), and diarrhea and constipation (scored 1 to 5) was evaluated before and after the intervention and then after nine months follow-up. RESULTS:Twenty-three patients in the synbiotic group and 33 patients in the placebo group completed the study (age = 39.8±12.7 years, 78.6% female). After treatment, more reduction in abdominal pain frequency was observed with synbiotic compared with placebo (score reduction 4.2±1.8 vs. 1.9±1.5, P<0.001). Diarrhea frequency was decreased in the synbiotic group, but not in the placebo group (score reduction 1.9±1.2 vs. 0.0±0.5, P<0.001). Decrease in constipation frequency was the same between the two groups (score reduction 0.9±1.2 vs. 0.8±1.1, P=0.561). After nine months follow-up, abdominal pain frequency was decreased (P=0.016), constipation frequency was increased (P<0.001), and diarrhea frequency remained unchanged in the synbiotic group (P=1.000). In the placebo group, abdominal pain frequency was increased (P<0.001), constipation frequency remained unchanged (P=0.553), and diarrhea frequency was increased (P<0.001). CONCLUSION:Bacillus Coagulans improves abdominal pain and diarrhea in IBS patients. Further studies on a larger sample of patients are warranted.

SUBMITTER: Rogha M

PROVIDER: S-EPMC4129566 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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The efficacy of a synbiotic containing Bacillus Coagulans in treatment of irritable bowel syndrome: a randomized placebo-controlled trial.

Rogha Mehran M Esfahani Mozhdehalsadat Zahiri MZ Zargarzadeh Amir Houshang AH

Gastroenterology and hepatology from bed to bench 20140101 3

<h4>Aim</h4>We aimed to evaluate the efficacy of a synbiotic containing Bacillus Coagulans in treatment of IBS.<h4>Background</h4>Some studies have shown the efficacy of probiotics in the treatment of irritable bowel syndrome (IBS).<h4>Patients and methods</h4>Adult IBS patients (n=85) were randomized to receive a synbiotic containing Bacillus Coagulans or placebo for 12 weeks. Frequency of IBS symptoms including abdominal pain (scored 1 to 7), and diarrhea and constipation (scored 1 to 5) was e ...[more]

PMID: 25120896

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Project description:ObjectivesCurrent irritable bowel syndrome (IBS) treatments have limited efficacy and probiotics like Bacillus clausii (B. clausii) were found to be effective in the management of several gastrointestinal disorders. This phase III trial assessed the efficacy and safety of adding B. clausii (four strains: O/C, N/R, SIN, T), versus placebo, to conventional treatment of pediatric IBS in Mexico.MethodsPatients aged 6-17 years 11 months with IBS (Rome IV) for at least 2 months were randomized to receive either B. clausii (oral suspension, total dose 4 billion spores/day) or placebo once daily for 8 weeks. All patients also received conventional treatment. The primary endpoint was the difference in the proportion of patients with clinical improvements at Week 8 (Global Assessment Questions [GAQ]). Secondary endpoints included responders by Subject's Global Assessment of Relief for Children with IBS (SGARC); number/consistency of stools; abdominal distention/bloating; abdominal pain/intensity; and IBS behavior.Results73.6% (95% confidence interval [CI] 67.3-80.0; B. clausii n = 129) and 78.5% (95% CI 72.5-84.4; placebo n = 130) of patients had symptom improvement (p = 0.8182). For Week 8 SGARC, 19.2% (B. clausii) and 20.9% (placebo) reported complete symptom relief. Stool evaluations, bloating, abdominal pain/intensity, and IBS behavior were similar between groups. Both treatments were well tolerated.ConclusionNo significant differences in efficacy between B. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30-40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less psychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups.Eudract number2018-004519-31.

Project description:ObjectiveTo investigate whether placebo effects can experimentally be separated into the response to three components-assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship-and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components.DesignA six week single blind three arm randomised controlled trial.SettingAcademic medical centre.Participants262 adults (76% women), mean (SD) age 39 (14), diagnosed by Rome II criteria for and with a score of > or =150 on the symptom severity scale.InterventionsFor three weeks either waiting list (observation), placebo acupuncture alone ("limited"), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence ("augmented"). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks.Main outcome measuresGlobal improvement scale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life.ResultsAt three weeks, scores on the global improvement scale were 3.8 (SD 1.0) v 4.3 (SD 1.4) v 5.0 (SD 1.3) for waiting list versus "limited" versus "augmented," respectively (P<0.001 for trend). The proportion of patients reporting adequate relief showed a similar pattern: 28% on waiting list, 44% in limited group, and 62% in augmented group (P<0.001 for trend). The same trend in response existed in symptom severity score (30 (63) v 42 (67) v 82 (89), P<0.001) and quality of life (3.6 (8.1) v 4.1 (9.4) v 9.3 (14.0), P<0.001). All pairwise comparisons between augmented and limited patient-practitioner relationship were significant: global improvement scale (P<0.001), adequate relief of symptoms (P<0.001), symptom severity score (P=0.007), quality of life (P=0.01). Results were similar at six week follow-up.ConclusionFactors contributing to the placebo effect can be progressively combined in a manner resembling a graded dose escalation of component parts. Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component.Trial registrationClinical Trials NCT00065403.

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The efficacy of a synbiotic containing Bacillus Coagulans in treatment of irritable bowel syndrome: a randomized placebo-controlled trial.

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The efficacy of a synbiotic containing Bacillus Coagulans in treatment of irritable bowel syndrome: a randomized placebo-controlled trial.

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