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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07355634
Eligibility Criteria:
Inclusion Criteria:
1. Adult males or females age ≥ 25 years
2. Ability to read and speak English
3. Dysbiosis (≥3 on GA-Map Dysbiosis Score) on a stool test (GI360 Profile, Doctor's Data, St. Charles, Illinois)
Exclusion Criteria:
1. Daily use within the past month of any probiotic or prebiotic supplement
2. Current diagnosis of inflammatory bowel disease, including Crohn's or ulcerative colitis
3. Current daily usage of non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors (PPI), or antibiotic medications
4. Current daily tobacco smoker
5. Known allergies to any substance in the study products
6. Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
7. Current diagnosis of any other chronic health condition (e.g., cancer, chronic kidney disease) deemed clinically contraindicated for the study protocol
8. Current participation in another clinical trial
9. Participants unable to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT07355634
Study Brief:
Protocol Section:
NCT07355634