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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT04823533
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adults of ≥ 18 to \& 65 years old of age.
2. Able to provide written consent.
3. Willing to provide stool samples and complete questionnaires, records, and diaries associated with the study
4. Willingness to discontinue consumption of probiotic supplements for the duration of the study.
Exclusion Criteria:
1. Concurrent consumption of probiotics. Subjects will be eligible for participation, however, after a four (4) week wash-out period.
2. Known to be pregnant or breastfeeding or planning on becoming pregnant in the next two (2) months.
Positive pregnancy test in women of childbearing potential.
3. Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit. The screened participant would be eligible to participate four (4) weeks after completing their course of antibiotics (wash-out period).
4. Subject with diabetes or metabolic diseases.
5. Subject with depression or psychiatric and neurological diseases.
6. Subject with IBS or gastrointestinal diseases.
7. Subject with immune disorders or with possible immune-deficient status (e.g. due to surgery).
8. Milk or soy allergy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04823533
Study Brief:
Protocol Section:
NCT04823533