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Probiotic
Probiotic Supplement for Irregular Bowel Movements
N/A
Waitlist Available
Led By Anthony Bier, MD
Research Sponsored by PepsiCo Global R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
In good general health and good oral health (no active or uncontrolled diseases or conditions).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
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.
Who is the study for?
Healthy adults aged 18-65 with a BMI of 18.5 to 34.9, experiencing an average of more than 3 but less than 6 bowel movements per week without laxatives. Participants must not be pregnant, avoid certain medications and vaccines during the study, maintain their usual diet, and use reliable birth control if applicable.Check my eligibility
What is being tested?
The trial is testing whether taking a capsule containing B. coagulans Unique IS2 improves bowel movement frequency and quality in healthy adults compared to a placebo over one month. The study measures changes from baseline stool frequency at weekly intervals using daily diaries.See study design
What are the potential side effects?
While specific side effects are not listed for B. coagulans Unique IS2, probiotics can sometimes cause digestive symptoms like gas or bloating initially as the body adjusts to them.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My vital signs and physical exam results are normal or acceptable for the study.
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I am in good overall health with no uncontrolled diseases.
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I have 3 to 6 natural bowel movements weekly without laxatives and feel emptied.
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I am between 18 and 65 years old and consider myself healthy.
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I agree not to get a COVID-19 vaccine during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Gastrointestinal quality of life index
Stool frequency
Stool quality
Other outcome measures
Fecal microbiome composition
Ratio of complete spontaneous bowel movements (SBMs) to total bowel movements
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bacillus coagulansExperimental Treatment1 Intervention
2 billion CFU Bacillus coagulans Unique IS2 per capsule
Group II: PlaceboPlacebo Group1 Intervention
Appearance-matched capsule
Find a Location
Who is running the clinical trial?
PepsiCo Global R&DLead Sponsor
89 Previous Clinical Trials
12,518 Total Patients Enrolled
Anthony Bier, MDPrincipal InvestigatorNutrasource Pharmaceutical and Nutraceutical Services, Inc.
6 Previous Clinical Trials
183 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You changed your diet significantly (such as starting a new diet, increasing or decreasing your fiber intake) within the 4 weeks before the study.You have participated in another research study involving medicine within the last 30 days. If the medicine you took is still affecting you, you may not be eligible for this study.I don't have any health issues or take anything that could interfere with the study.My vital signs and physical exam results are normal or acceptable for the study.Agree not to have any treatments during the defined timeframes outlined in the protocol.I am in good overall health with no uncontrolled diseases.You have a history of drug or alcohol abuse within the last 12 months.You have a history of certain medical conditions such as heart disease, high blood pressure, diabetes, bipolar disorder, thyroid disease, immune disorders, cancer, or other significant health issues that may put you at risk or affect your ability to participate in the study.I have 3 to 6 natural bowel movements weekly without using aids.I have a history of digestive issues or surgeries excluding appendectomy or hernia repair.I have 3 to 6 natural bowel movements weekly without laxatives and feel emptied.You are allergic to any of the study products or their ingredients, or you cannot take the emergency medications provided in case of adverse reactions.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.I have had either constipation or diarrhea as defined in the study.I have not had major surgery in the last 3 months and do not plan any during the study.I have not been vaccinated for COVID-19 in the last 2 weeks, and I do not currently have COVID-19 or long-lasting symptoms from a past infection.You should have a BMI between 18.5 and 34.9 kg/m2.I am between 18 and 65 years old and consider myself healthy.I have been using a hormonal contraceptive method for at least 3 months.I agree not to get a COVID-19 vaccine during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Bacillus coagulans
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment open to individuals over 30 years of age?
"This research is only open to those aged between 18 and 65 years of age, as outlined in the eligibility criteria."
Answered by AI
Is there an opportunity to join this research project?
"This research is in search of 144 volunteers aged 18 to 65 who have experienced irregularity in their bowel movements. To qualify, participants must have had an average of 3-6 CSBMs per week over the past 4 weeks and possess a BMI between 18.5 to 34.9 kg/m2 (inclusive). Additionally, they must agree not to change dietary habits nor take any pro- or prebiotic supplements during the trial period; maintain normal vital signs and physical examinations; remain generally healthy with no active or uncontrolled diseases; abstain from anal intercourse for 72 hours prior to fecal sample collection; as well as decline CO"
Answered by AI
Are there vacancies available for participants in this clinical investigation?
"Clinicaltrials.gov provides information indicating that this clinical trial commenced on April 11th 2022 and has recently been updated on September 13th of the same year. The study is hereby inviting prospective candidates to participate in their research project."
Answered by AI
How many participants is the clinical trial taking on?
"Affirmative, according to the clinicaltrials.gov database this research study is actively recruiting participants. It was first published on April 11th 2022 and has been updated as recently as September 13th. The investigation requires 144 individuals for participation at one site of enrolment."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
How old are they?
18 - 65
What site did they apply to?
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: Nutrasource Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
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