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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stool Frequency
- Sponsor
- PepsiCo Global R&D
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Stool frequency
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and female adult participants who are 18 to 65 years of age (inclusive).
- •In good general health and good oral health (no active or uncontrolled diseases or conditions).
- •Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
- •Have normal (or acceptable to the investigator) vital signs (blood pressure and heart rate) at screening (Visit 1) and baseline (Visit 2) and normal (or acceptable to the investigator) physical exam findings (if applicable) at screening.
- •Individuals of childbearing potential must agree to practice a medically acceptable form of birth control for a defined timeframe prior to the start of run-in and throughout the study to avoid pregnancy, including:
- •use for at least 3 months prior to run-in: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), hormone implant (e.g., Norplant System), or intrauterine devices (e.g., Mirena); or
- •use for at least 1 month prior to run-in: double-barrier method (e.g., condom with diaphragm or condom with cervical cap), non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual intercourse that can result in pregnancy; or
- •vasectomy of partner at least 6 months prior to run-in. Individuals with the potential to impregnate others must agree to avoid pregnancy by using the double-barrier method mentioned above or complete abstinence from sexual intercourse that can result in pregnancy.
- •Agree to refrain from treatments in the defined timeframes as outlined in Section 6.
- •Agree not to change current dietary habits (with the exception of avoiding pro- and prebiotic supplements), smoking and alcohol consumption habits, and activity/training levels starting from the beginning of the run-in period and for the duration of the study.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Stool frequency
Time Frame: Change from 7 day average prior to baseline versus 7 day average in fourth week. A significant increase is desirable.
Number of daily bowel movements
Secondary Outcomes
- Stool quality(Change from 7 day average prior to baseline to week 1, 2, 3 and 4 average scores. An increase from baseline stool frequency in the B. coagulans group at weeks 1,2,3,4 which is significantly better than the change in the placebo group, is desirable.)
- Stool frequency(Change from 7 day average prior to baseline to week 1, week 2 and week 3 averages. An increase from baseline stool frequency at Weeks 1, 2, or 3 in the B coagulans group, which is significantly better than the change in the placebo group, is desirable.)
- Gastrointestinal quality of life index(Change from baseline score to week 4 score. An improved score is desirable.)