Capsule for Stool Frequency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stool FrequencyCapsule - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess whether taking B. coagulans Unique IS2 improves bowel movement frequency, quality, and related symptoms and quality of life in adults with irregular bowel movements.

Treatment Effectiveness

Study Objectives

0 Primary · 3 Secondary · Reporting Duration: 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.

Week 1
Stool quality
Week 3
Stool frequency
Week 4
Gastrointestinal quality of life index
Week 4
Ratio of complete spontaneous bowel movements (SBMs) to total bowel movements
Week 4
Fecal microbiome composition

Trial Safety

Trial Design

2 Treatment Groups

Bacillus coagulans
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

144 Total Participants · 2 Treatment Groups

Primary Treatment: Capsule · Has Placebo Group · N/A

Bacillus coagulans
Other
Experimental Group · 1 Intervention: Capsule · Intervention Types: Other
Placebo
Other
PlaceboComparator Group · 1 Intervention: Capsule · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

PepsiCo Global R&DLead Sponsor
84 Previous Clinical Trials
7,775 Total Patients Enrolled
Anthony Bier, MDPrincipal InvestigatorNutrasource Pharmaceutical and Nutraceutical Services, Inc.
5 Previous Clinical Trials
166 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects had an average of 3.0 to 6.0 complete spontaneous bowel movements per week over 4 weeks prior to screening and during the run-in period.
You should have a BMI between 18.5 and 34.9 kg/m2.
The patient should have normal vital signs and physical exam findings at both the screening and baseline visits.
The text describes how people participating in the study must have either been using contraceptives for at least 3 months prior to the start of the study, or been using a double-barrier method of birth control for at least 1 month prior, or had a vasectomy performed at least 6 months prior
Do not change your current diet (except for 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.
Healthy people aged 18 to 65.
Generally healthy, with no active diseases or conditions
Agree not to have any treatments during the defined timeframes outlined in the protocol.
I agree to not have anal sex for 72 hours before I give a fecal sample.
I agree not to receive a vaccine for COVID-19 throughout the duration of the study.

Who else is applying?

What state do they live in?
Ontario100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: Nutrasource Clinical Trial Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%