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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 44
Population
Patients with IBS
Methods
Randomized Controlled Trial
  • Highly Cited

Abstract

Background: Symptoms of irritable bowel syndrome (IBS) can have a profound impact on emotional health and quality of life, and current treatments are sometimes unsatisfactory for patients facing this lifelong disease. Probiotics, which can normalize gastrointestinal microflora, may alleviate symptoms of IBS.

Objective: This preliminary controlled study was conducted to evaluate the effects of the probiotic Bacillus coagulans GBI-30, 6086 on IBS symptoms.

Methods: This was a randomized, double-blind, parallel-group, placebo-controlled clinical trial involving 44 subjects who received either placebo or B coagulans GBI-30, 6086 once a day for 8 weeks. Self-assessments of the severity of IBS symptoms (abdominal pain and bloating) were recorded every day for 8 weeks. Because baseline values were significantly different between the 2 study groups, within-group analysis was conducted.

Results: Improvements from baseline abdominal pain and bloating scores in the B coagulans GBI-30, 6086 group were statistically significant for all 7 weekly comparisons (P < 0.01). In the placebo group, only changes in abdominal pain scores at weeks 6 and 8 achieved statistical significance (P < 0.05). No treatment-related adverse events or serious adverse events were reported during the 8-week study period.

Conclusions: Preliminary data suggest that the patented B coagulans GBI-30, 6086 probiotic may be a safe and effective option for the relief of abdominal pain and bloating for patients with IBS. Larger, extended trials are needed to verify these results.

Research Insights

  • Improvements from baseline abdominal pain and bloating scores in the B coagulans GBI-30, 6086 group were statistically significant for all 7 weekly comparisons (P < 0.01).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    once a day for 8 weeks (specific dosage not stated)
  • Improvements from baseline abdominal pain and bloating scores in the B coagulans GBI-30, 6086 group were statistically significant for all 7 weekly comparisons (P < 0.01).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    once a day for 8 weeks (specific dosage not stated)

Adverse Events Reported

  • Bacillus coagulans GBI-30, 6086Overall tolerability

    No treatment-related adverse events or serious adverse events were reported during the 8-week study period.

    Finding
    Reported
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