BridgeMD
New treatment option for Environmental Enteric Dysfunction (EED)
Official title Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
ClinicalTrials.gov ID: NCT07207434
What this study is testing
What is Oral Vancomycin?
Oral Vancomycin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for environmental enteric dysfunction (eed).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only
You may be able to join if
- 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...
- Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan...
- Presence of any of the following WASH conditions -
- use surface water, unimproved water, or limited water for drinking; OR
- use surface water, unimproved water, or limited water for cooking; OR
You likely can't join if
- 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
See the full eligibility 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...
- Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli...
- Presence of any of the following WASH conditions -
- use surface water, unimproved water, or limited water for drinking; OR
- use surface water, unimproved water, or limited water for cooking; OR
- use surface water, unimproved water, or limited water for washing utensils; OR
- practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR
- lack facility or have limited facility for handwashing
- 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 how well it works
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Matiari, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Matiari, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.