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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

NCT05123664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2024-03-06

No results posted yet for this study

Summary

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).

Conditions

  • Stool Frequency

Interventions

OTHER

Capsule

1 cap daily at same time of the day with or without food for 4 weeks

Sponsors & Collaborators

  • PepsiCo Global R&D

    lead INDUSTRY

Principal Investigators

  • Anthony Bier, MD · Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2023-12-20
Completion
2023-12-20

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05123664 on ClinicalTrials.gov