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New treatment option for Environmental Enteric Dysfunction (EED)
Official title The Maternal EED Study
ClinicalTrials.gov ID: NCT05862363
What this study is testing
- What it's testing
- Undernutrition among women of reproductive age is more common in South Asia than in any other region. In South Asia, the prevalence of maternal undernutrition varies between 10 and 40%.
- Which group you join is decided by chance.
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 35, women only. Healthy volunteers may be eligible.
You may be able to join if
- for pregnant low-BMI women
- Bangladeshi female, age 18-35 years
- BMI 20-24.9 kg/m2
- Middle-upper socioeconomic class (≥ $11/day family income)
- Functional dyspepsia
You likely can't join if
- Exclusion criteria for pregnant low-BMI women
- Received antibiotics during the last one month
- Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity
- Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days Exclusion criteria for...
- Severe anemia (\<8 g/dl), TB and other chronic diseases, including diabetes mellitus, urogenital infections or any congenital disorder or deformity
- Pregnancy, lactation, drug abuse, known psychiatric disorders
See the full eligibility criteria
- for pregnant low-BMI women
- Bangladeshi female, age 18-35 years
- BMI 20-24.9 kg/m2
- Middle-upper socioeconomic class (≥ $11/day family income)
- Functional dyspepsia
- Willing to sign the consent form
- Willing to provide biological samples during the study period of 6 months for non-pregnant low-BMI women 1. Bangladeshi female, age 18-35 years
- BMI \<18.5 kg/m2
- No antibiotics for 1 month
- Willing to sign the consent form
- Willing to undergo endoscopy and biopsy
- Willing to provide biological samples during the study period of 6 months
- Willing to receive food supplementation for 3 months for normal-BMI non-pregnant women
- Bangladeshi female, age 18-35 years
- BMI 20-24.9 kg/m2
- Middle-upper socioeconomic class (≥ $11/day family income)
- Functional dyspepsia
- Willing to sign the consent form
- Willing to provide biological samples during the study period of 6 months for normal-BMI pregnant women
- Bangladeshi female, age 18-35 years
- BMI 20-24.9 kg/m2
- Middle-upper socio-economic class (≥ $11/day family income)
- Enrolled at the end of first-trimester of pregnancy (before 14 weeks of gestation)
- Willing to sign the consent form
- Willing to undergo endoscopy and biopsy
- Willing to provide biological samples during the study period
- Willing to let anthropometry and biological sample collection from her newborn for the first 6 months of life
- Exclusion criteria for pregnant low-BMI women
- Received antibiotics during the last one month
- Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity
- Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days Exclusion criteria for non-pregnant low-BMI women
- Severe anemia (\<8 g/dl), TB and other chronic diseases, including diabetes mellitus, urogenital infections or any congenital disorder or deformity
- Pregnancy, lactation, drug abuse, known psychiatric disorders
- High clinical suspicion of cancer or other chronic or acute diseases that may cause malnutrition. Adult participants who fulfill the inclusion criteria and are not excluded through history and clinical examination will...
- Chest x-ray
- Urine for R/E
- Ultrasonography of whole abdomen
- Fasting blood glucose/ HbA1c
- Stool for OBT (occult blood test)
- Cancer markers (ie. CEA, CA 15.3, CA 19.9)
- Known allergy to any components of nutrition intervention
- Nugent Score/Amsel Criteria to exclude bacterial vaginosis: A Nugent score 3-4 is consistent with Bacterial vaginosis (BV). The modified Amsel criteria with a cut-off value of 2 (pH+VD; sensitivity 71%, specificity 90%...
- Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days Exclusion criteria for non-pregnant normal-BMI women
- Received antibiotics during the last one month
- Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity
- Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days Exclusion criteria for pregnant normal-BMI women
- Multiple pregnancy (carrying two or more fetuses)
- Threatened abortion, persistent pervaginal bleeding, or cervical incompetence
- History of three or more consecutive abortions
- History of gestational diabetes, macrosomia, gestational hypertension, preeclampsia/eclampsia in a prior pregnancy
- Active disease/complications requiring acute phase treatment in a hospital
- Tuberculosis
- Severe anemia (Hb concentration \< 8 mg/dl)
- Antibiotic use (ongoing or within last two weeks before the onset of intervention)
- Taking medications such as insulin, thyroid hormones, glucocorticoids
- Chronic diseases, such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, Crohn's disease, ulcerative colitis, diabetes mellitus...
- Known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder
- Having known history of allergy to the therapeutic agents
- Having a plan to move or deliver outside the study area
- Known allergy to any components of nutrition intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Dhaka Division, Bangladesh
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Dhaka Division, Bangladesh. 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.