Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT05750433
Eligibility Criteria:
Inclusion Criteria:
* Equal numbers of healthy male and female volunteers between 18-75 years old with BMI scores of 18.5 to 34.9.
Exclusion Criteria:
* Individuals less than 18years of age or greater than 75years of age.
* If an individual's BMI is outside of 18.5-34.9.
* History of taking antibiotics and/or probiotics/prebiotics supplementation within 2months of starting antibiotics.
* If individual is on any medications and dietary supplements that would influence the endpoints of the study, such as statins, metformin, NSAIDs and MAO inhibitors.
* If individuals with diagnosis with cancer, liver or kidney disease, gastrointestinal diseases and metabolic disorders.
* Pregnant and breastfeeding women.
* Additionally inclusion and exclusion in the study will be determined case by case based on self reported alcohol and supplement use.
* If individual is unable to adhere to study protocol such as consuming capsules for a total 45days, providing stool or blood samples and attending scheduled clinic visits.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05750433
Study Brief:
Protocol Section:
NCT05750433