ACTIVE_NOT_RECRUITING

Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement

Quick Facts

Study Start:2025-02-03

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06794619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Locations (Sites)

Princeton Consumer Research

Saint Petersburg, Florida, 33702

United States

Collaborators and Investigators

Sponsor: Olly, PBC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03

Study Completion Date2025-08

Study Record Updates

Study Start Date2025-02-03

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Healthy