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:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT07243756
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adults aged 18-65.
2. Willing and able to provide informed consent.
3. Able and willing to comply with study procedures, including pill ingestion, stool collection, follow and record dietary instructions, and fill questionnaires.
Exclusion Criteria:
1. History of gastrointestinal diseases (e.g., Crohn's disease, irritable bowel syndrome, small intestinal bacterial overgrowth).
2. History of abdominal surgery that may impact gastrointestinal function (e.g., bowel resection, bariatric surgery).
3. Known allergies or intolerances to medical devices or ingestible capsules.
4. Recent antibiotic use (within 3 months) that may affect gut microbiome results.
5. Use of medications that alter GI motility such as laxatives or prokinetics.
6. Known anatomical abnormalities or strictures in the GI tract that increase the risk of obstruction.
7. Pregnant, planning pregnancy or breastfeeding, since pregnancy and breastfeeding affect the microbiome, Exclusion of pregnancy will be confirmed by the date of the last menstrual period.
8. Participation in another investigational trial within the last 30 days.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07243756
Study Brief:
Protocol Section:
NCT07243756