Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement

Olly, PBC

Status

Active, not recruiting

Conditions

Healthy

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Dietary Supplement with actives

Study type

Interventional

Funder types

Industry

Identifiers

NCT06794619

OLLCLI1F

Details and patient eligibility

About

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

Enrollment

34 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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