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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT06196450
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18 years or older in the first trimester or early second trimester of pregnancy, living in defined geographical areas of Bangladesh (Matlab), Pakistan, Senegal and Zambia, where it can be assumed that environmental enteropathy is universal
Exclusion Criteria:
* Potential participants will not be enrolled if they:
* have had diarrhea, defined as the passage of three or more loose stools per 24 hours, in the preceding 14 days
* have taken antibiotics or probiotics in the preceding 14 days
* have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days
* have severe pallor (hemoglobin concentration \<8g/dl)
* have any chronic disease, illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy
* have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)
* have the plan to observe fast at any time during the intervention period
* have the plan to leave the study area within the follow-up period
* are included in any other intervention trial
* belong to a household from which another woman is already enrolled in the study
but may be enrolled if/when these disqualifiers have expired
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06196450
Study Brief:
Protocol Section:
NCT06196450