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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT07207434
Eligibility Criteria:
Inclusion criteria
* Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \[GA\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent
* Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR.
* Presence of any of the following WASH conditions -
1. use surface water, unimproved water, or limited water for drinking; OR
2. use surface water, unimproved water, or limited water for cooking; OR
3. use surface water, unimproved water, or limited water for washing utensils; OR
4. practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR
5. lack facility or have limited facility for handwashing
Exclusion criteria
Potential participants will not be enrolled if they:
* have MUAC ≥30 cm
* are carrying more than one fetus (i.e., multiple pregnancy)
* have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days
* have fever or an active infection
* 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 anemia as determined using finger stick Hb \< 8 g/dl
* have a history of chronic digestive disease
* have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)
* have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)
* have known drug hypersensitivity/allergy/intolerance
* have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy
* are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation
* have a plan to observe fast any time during the intervention period
* have a plan to leave the study area within the follow-up period
* are participating in any other interventional 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
Maximum Age:
49 Years
Study:
NCT07207434
Study Brief:
Protocol Section:
NCT07207434