Clinical trial NCT06794619: Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement
Official title: Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Olly, PBC
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Changes in Gastrointestinal Symptoms (GSRS) Scores
timeFrame: from enrollment to end of study at 10 weeks
measure: Changes in Stool Consistency (Bristol Stool Chart)
timeFrame: from enrollment to end of study at 10 weeks
Secondary outcomes:
measure: Changes in Immune Biomarkers (Blood Samples) Levels
timeFrame: from enrollment to end of study at 10 weeks
measure: Changes in Gut Microbiome Composition (Stool Samples)
timeFrame: from enrollment to end of study at 10 weeks
Other outcomes:
measure: Changes in Daily Quality of Life (DQLQ) Scores
timeFrame: from enrollment to end of study at 10 weeks
measure: Changes in Daily Diet and Symptoms (Daily Diary)
timeFrame: from enrollment to end of study at 10 weeks
measure: Changes During Initial Dose Effects (24-Hour Questionnaire)
timeFrame: from enrollment to end of study at 10 weeks
Locations:
city: Saint Petersburg
country: United States
facility: Princeton Consumer Research
state: Florida
Study officials:
References: