💬In plain words
What the trial is, and whether it could suit you
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterized by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting.
Knowledge gap: To date the focus of research on childhood stunting has been on the young child. It is increasingly appreciated, however, that stunting often begins in utero and the focus has shifted to women's health and pregnancy. Results from rural Bangladesh reveal poor gestational weight gain that ultimately leads to intrauterine growth restriction, low birth weight and ultimately stunting and wasting. Another study recently completed in slum settlements of Dhaka, Bangladesh demonstrate
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
All pregnant women in their first or early second trimester of pregnancy, residing in the icddr,b service area of Matlab, who meet the eligibility criteria decribed below.
Inclusion criteria
1. 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
AND
2. 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.
AND
3. 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:
1. have MUAC ≥30 cm
2. are carrying more than one fetus (i.e., multiple pregnancy)
3. have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days
4. have fever or an active infection
5. have taken antibiotics or probiotics in the preceding 14 days
6. have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days
7. have severe anemia as determined using finger stick Hb \< 8 g/dl
8. have a history of chronic digestive disease
9. have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)
10. have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)
11. have known drug hypersensitivity/allergy/intolerance
12. have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy
13. 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
14. have a plan to observe fast any time during the intervention period
15. have a plan to leave the study area within the follow-up period
16. are participating in any other interventional trial
17. belong to a household from which another woman is already enrolled in the study
but may be enrolled if/when these disqualifiers have expired.
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