Bacillus coagulans Unique IS2 in Constipation: A Double-Blind, Placebo-Controlled Study

Abstract

Functional constipation has a high prevalence in both adults and children affecting quality of life. Evidence suggests that probiotics can reduce the symptoms of constipation. As the effects of probiotics are strain specific, the efficacy of Bacillus coagulans Unique IS2 in the treatment of functional constipation in adults was evaluated. Subjects (n = 100) diagnosed with functional constipation were supplemented with either B. coagulans Unique IS2 (2 billion CFU) or placebo capsules once daily for 4 weeks. Subjects were evaluated for treatment success (defined as three or more spontaneous stools per week), stool consistency, difficulty of defecation, defecation and abdominal pain. By the end of the fourth week, there was a statistically significant (p < 0.001) increase in number of bowel movements in the probiotic treated group as compared to placebo. Ninety eight percent of subjects in the probiotic group achieved normal stool consistency as compared to placebo (74%). Moreover, there was relief from symptoms of incomplete evacuation, painful defecation and abdominal pain associated with constipation in probiotic treated group as compared to placebo. In conclusion, B. coagulans Unique IS2 significantly decreased the symptoms of constipation indicating effectiveness of the strain in the treatment of constipation.

Trial registration: CTRI/2017/11/010539.

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Correspondence to Ratna Sudha Madempudi.

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This study was conducted in compliance with the code of conduct for research involving human volunteers as issued by the International Conference on Harmonisation–Good Clinical Practice (ICH-GCP), Indian Council of Medical Research guidelines (ICMR; ethical guidelines for biomedical research on human subjects) and the principles of the Declaration of Helsinki. Informed consent forms were approved by the ethical committees of study sites and the trial was registered prospectively with the clinical trial registry of India (CTRI/2017/11/010539). The study was initiated after obtaining informed consent.

Competing Interests

R.S.M., J.N. and J.J.A. are employed by Unique Biotech Ltd. which is a manufacturer of probiotics. They wish to state that the study was conducted independently with no intervention on their part during the duration of the study.

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Madempudi, R.S., Neelamraju, J., Ahire, J.J. et al. Bacillus coagulans Unique IS2 in Constipation: A Double-Blind, Placebo-Controlled Study. Probiotics & Antimicro. Prot. 12, 335–342 (2020). https://doi.org/10.1007/s12602-019-09542-9

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Keywords

  • Probiotic
  • B. coagulans unique IS2
  • Constipation
  • Bowel movements
  • Abdominal pain