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Active, Not Recruiting

NCT Number: NCT06794619

Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princeton Consumer Research

St. Petersburg, Florida, 33702, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Placebo

Dietary Supplement with actives

Dietary Supplement

Dietary Supplement containing probiotic and prebiotic ingredients

Primary outcomes

  1. Changes in Gastrointestinal Symptoms (GSRS) Scores

    Time frame: from enrollment to end of study at 10 weeks

    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.

  2. Changes in Stool Consistency (Bristol Stool Chart)

    Time frame: from enrollment to end of study at 10 weeks

    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.

Secondary outcomes

  1. Changes in Immune Biomarkers (Blood Samples) Levels

    Time frame: from enrollment to end of study at 10 weeks

    Blood sample analysis will focus on immune function biomarkers counts. Changes in immune biomarkers will be compared between baseline, active treatment, and placebo periods.

  2. Changes in Gut Microbiome Composition (Stool Samples)

    Time frame: from enrollment to end of study at 10 weeks

    Stool samples will be analyzed for changes in microbial diversity and specific bacterial populations, which may indicate changes in gut health.

    Comparisons will be made between active treatment and placebo periods to identify any significant shifts in the microbiome.

Other outcomes

  1. Changes in Daily Quality of Life (DQLQ) Scores

    Time frame: from enrollment to end of study at 10 weeks

    DQLQ scores will be compared across different phases to assess any impacts of the supplement on participants' well-being and daily functioning.

    Changes in quality of life will be analyzed at baseline, end of each treatment period, and post-washout.

  2. Changes in Daily Diet and Symptoms (Daily Diary)

    Time frame: from enrollment to end of study at 10 weeks

    Changes in daily food intake, symptom levels, and stool consistency from the diaries will be analyzed to identify any patterns or correlations between dietary habits and digestive health outcomes. This data will provide exploratory insights into lifestyle factors that may influence supplement effects.

  3. Changes During Initial Dose Effects (24-Hour Questionnaire)

    Time frame: from enrollment to end of study at 10 weeks

    Short-Term Effects on Symptoms (24-Hour Data). The 24-hour questionnaire data following the initial dose will be used to capture any immediate digestive effects of the supplement.

    Changes in reported symptoms within this initial period will be compared between the active supplement and placebo groups.

Sponsors and collaborators

Lead sponsor

Olly, PBC

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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