NCT04997187

Effect of Bacillus Coagulans in Adults With With Functional Constipation

Effect of Bacillus Coagulans on Various Symptoms and Fecal Microbial Diversity in Adults With With Functional Constipation: a Randomized, Double-blinded, Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks.

Detailed description

A previous study has indicated that Bacillus coagulans provided control of abdominal pain, less discomfort during defecation, and a more normalized defecation style, especially in adults with with functional constipation. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans various symptoms and fecal microbial diversity in adults with with functional constipation for 8 weeks; the safety of the compound are also evaluated. The Investigators examine constipation visual analogue scale, Bristol Stool Form Scale type 3 \& 4 ratio, visual analogue scale for irritable bowel syndrome (VAS-IBS) questionnaire score, IBS-symptom severity scale, IBS quality-of-life questionnaire score, fecal microbial diversity at baseline, as well as after 8 weeks of intervention. Eighty adults were administered either 400 mg of Bacillus coagulans or a placebo each day for 8 weeks.

Conditions

• Constipation - Functional

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bacillus coagulans group	Bacillus coagulans 400 mg/day for 12 weeks
DIETARY_SUPPLEMENT	Control group	Placebo 400 mg/day for 12 weeks

Timeline

• Start date: 2021-07-20
• Primary completion: 2022-02-27
• Completion: 2022-04-15
• First posted: 2021-08-09
• Last updated: 2026-01-06

Locations

1 site across 1 country: South Korea