Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement

NCT06794619 | Active Not Recruiting

• 1 other identifier: OLLCLI1F
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Changes in Gastrointestinal Symptoms (GSRS) Scores

  Weekly GSRS scores will be analyzed to assess changes in the severity and frequency of gastrointestinal symptoms across the active and placebo arms. Data will be compared between the active supplement and placebo groups and within each participant across different time points to measure crossover effects.

  from enrollment to end of study at 10 weeks

• Changes in Stool Consistency (Bristol Stool Chart)

  Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.

  from enrollment to end of study at 10 weeks

Secondary Outcomes (2)

• Changes in Immune Biomarkers (Blood Samples) Levels

  from enrollment to end of study at 10 weeks

• Changes in Gut Microbiome Composition (Stool Samples)

  from enrollment to end of study at 10 weeks

Other Outcomes (3)

• Changes in Daily Quality of Life (DQLQ) Scores

  from enrollment to end of study at 10 weeks

• Changes in Daily Diet and Symptoms (Daily Diary)

  from enrollment to end of study at 10 weeks

• Changes During Initial Dose Effects (24-Hour Questionnaire)

  from enrollment to end of study at 10 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Dietary Supplement with actives

ACTIVE COMPARATOR

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.

Dietary Supplement: Dietary Supplement with actives

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Dietary Supplement with actives DIETARY_SUPPLEMENT

Dietary Supplement containing probiotic and prebiotic ingredients

Dietary Supplement with actives

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Olly, PBC: lead

Study Sites (1)

Princeton Consumer Research

St. Petersburg, Florida, 33702, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 27, 2025
• Study Start: February 3, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)