Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement

NCT ID: NCT06794619

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-08-31

Brief Summary

Randomized, Crossover, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with Daily Food Log, Stool Samples, Blood Draws, and Validated Questionnaires (GSRS, Bristol stool chart, and DQLQ) with Oral Dietary Supplement

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Oral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Dietary Supplement with actives

Oral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.

Group Type: ACTIVE_COMPARATOR

Dietary Supplement with actives

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement containing probiotic and prebiotic ingredients

Interventions

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement with actives

Dietary Supplement containing probiotic and prebiotic ingredients

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Olly, PBC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Princeton Consumer Research

St. Petersburg, Florida, United States

Countries

United States

Other Identifiers

OLLCLI1F

Identifier Type: -

Identifier Source: org_study_id