NCT05123664

A Prospective, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy of Bacillus Coagulans Unique IS2 on Improving Bowel Movement Characteristics, Gastrointestinal-related Symptoms and Quality of Life in Healthy Adult Participants

Completed NA Last updated 6 March 2024

What this trial tests

NA trial testing Capsule in Stool Frequency in 143 participants. Completed in 20 December 2023.

Timeline

11 April 2022

Primary endpoint
20 December 2023

20 December 2023

Quick facts

Lead sponsor	PepsiCo Global R&D
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	143
Start date	11 April 2022
Primary completion	20 December 2023
Estimated completion	20 December 2023
Sites	1 location across Canada

Drugs / interventions tested

• Capsule

Conditions studied

• Stool Frequency — all drugs for Stool Frequency →

Sponsor

PepsiCo Global R&D — full company profile →

Who can join

Adults 18 to 65, any sex, with Stool Frequency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective, randomized, placebo-controlled, double-blind study will be conducted to assess the efficacy of 2 billion CFU/day of B. coagulans Unique IS2 on improving bowel movement characteristics, gastrointestinal-related symptoms and quality of life in healthy adult participants who are experiencing more than 3.0 but less than 6.0 complete spontaneous bowel movements (CSBM) per week on average.

Following a run-in period of 14 days to assess participants' baseline bowel habits, they are randomized to either B. coagulans or placebo for one month. The primary endpoint is change from baseline at 4 weeks in stool frequency in the test product group compared to the placebo group for average number of daily bowel movements over the week prior to the study visits. Secondary endpoints are stool frequency at weeks 1, 2, 3, stool quality measured by Bristol stool type scores, and gastrointestinal quality of life index (GIQLI) scores and subcategories (social, physical, emotional, symptoms).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bacillus coagulans Unique IS2 improves stool characteristics in healthy adults with infrequent bowel movements: a randomized, double-blind, placebo-controlled trial.
   LeMoire A, Replogle R, Shinn L, Kamil A, et al · · 2025 · PMID 40456531 · DOI 10.1163/18762891-bja00072