Assessing the effects of a prebiotic and probiotic supplement on digestive health

Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement

This study is testing whether a supplement with prebiotics and probiotics can help people with mild to moderate digestive issues feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Olly, PBC (Industry-sponsored)
• Locations: 1 site (Saint Petersburg, Florida)
• Trial ID: NCT06794619 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effects of a dietary supplement containing prebiotics and probiotics on individuals with mild to moderate occasional digestive issues. It employs a randomized, crossover, double-blind, placebo-controlled design, ensuring that participants receive both the active supplement and a placebo at different times. Participants will maintain a daily food log, provide stool samples, undergo blood draws, and complete validated questionnaires to assess their digestive health. The study aims to gather comprehensive data on the supplement's impact on digestive comfort and overall well-being.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 50 who experience mild or moderate occasional digestive issues without chronic conditions.

Not a fit: Patients with diagnosed chronic digestive or immune conditions are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective dietary interventions for improving digestive health in individuals with occasional discomfort.

How similar studies have performed: Previous studies have shown promising results with similar prebiotic and probiotic interventions, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Subject is a healthy male or female between the ages of 18 - 50 years, inclusive;
* Subject indicates they have mild or moderate occasional digestive issues (bloating or mild discomfort) with no diagnosed chronic digestive or immune conditions;
* Subject has signed a written Informed Consent and is willing and able to attend all visits and comply with study instructions;
* Subject agrees to maintain their regular diet and exercise habits;
* Subject agrees to limit alcohol consumption to 1 drink per day or no more than 7 drinks per week.
* Females Only: Female subject of childbearing potential must agree to be on a form of birth control for at least 6 months prior to screening visit. Acceptable forms of birth control are: Abstinence (not having heterosexual sex), same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), vasectomized partner for at least 6 months prior to the screening visit. Birth control (such as the pills, intravaginal ring, or the arm implant) are not acceptable forms of birth control.
* Subject agrees not to take any dietary supplements or medications throughout the clinical study;
* Subject agrees to have four blood draws taken at the testing facility and agrees to collect stool samples (four times) as instructed.
* Subject has an active email address and is capable of completing online questionnaires.

Exclusion Criteria:

* Subject has severe digestive issues (e.g., IBS, Crohn's Disease, Ulcers, Severe Constipation, etc.);
* Subject has allergies to dietary supplements or their ingredients;
* Subject is currently taking medication(s) for a chronic condition;
* (Females of Child Bearing Potential only) Subject is pregnant, nursing, or planning to become pregnant;
* Subject has significant past/current medical history (e.g., previous diagnosis of gastrointestinal or metabolic conditions, cancer, liver or kidney disease);
* Subject has any disease or condition (e.g., hepatic, multiple sclerosis, high blood pressure, renal, Thrombosis/Phlebitis, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease) which in the opinion of the Investigator would compromise the safety of the subject;
* Subject has travel plans and would be unable to attend all study visits;
* Subject is currently taking any dietary supplements, vitamins and/or medications;
* Subject is currently taking probiotics related to digestion or any products that may impact gut microbiota (e.g. probiotic supplements, yogurt, and/or fermented drinks);
* Subject has used antibiotics in the last 3 months;
* Subject has a positive medical history for cancer within the past 5 years;
* Subjects has any planned surgeries and/or invasive medical procedures during the study;
* Subjects is considered unreliable or unlikely to be available for the duration of the study;
* Subject is an employee of the clinical site or the sponsor

Where this trial is running

Saint Petersburg, Florida

• Princeton Consumer Research — Saint Petersburg, Florida, United States (Recruiting)

Conditions Healthy