The Maternal EED Study
Small Intestinal Microbiota of Low Body Mass Index (BMI) & Normal BMI Women of Reproductive Age and Microbiota-directed Balanced Energy Protein (MD-BEP) Supplementation in Maternal Environmental Enteric Dysfunction (EED)
International Centre for Diarrhoeal Disease Research, Bangladesh
180 participants
Jan 2, 2023
INTERVENTIONAL
Conditions
Summary
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%. There is a scarcity of data on the contribution of small intestinal (SI) microbiota to pathogenesis of Environmental Enteric Dysfunction (EED) of malnutrition, as it is difficult to obtain gut biopsy specimens from malnourished individuals, especially children. The Bangladesh Environmental Enteric Dysfunction (BEED) study, involving participants who live in an urban slum (Mirpur) in Dhaka, provided an opportunity to examine the role of the duodenal microbiota in the pathogenesis of EED in children and also performed esophagogastroduodenoscopy (EGD) on thirty-eight 18-45-year-old malnourished (BMI\<18.5 kg/m2) women residing in the same resource-poor setting of Mirpur, Dhaka who failed to respond to an egg/milk/micronutrients- based nutritional intervention comparable to that given to children. In this intervention component, beginning at the end of the first trimester, low-BMI (\<18.5 kg/m2) pregnant women (aged 18-35 years) will be randomly assigned to receive either Microbiota-directed Balanced Energy Protein (MD-BEP) or Ready-to-Use-Supplementary Food Balanced Energy Protein (RUSF-BEP) for the duration of their pregnancy and during the first 3 postnatal months, in addition to standard antenatal care. A parallel cohort of age-matched normal-BMI pregnant women who will not receive any nutritional intervention will serve as a reference control group.
Eligibility
Inclusion Criteria35
- 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
- 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
- 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
- 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
- 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%, accuracy 88% or KOH+VD; sensitivity 75%, specificity 91%, accuracy 89%) might be considered for this purpose20.
- Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days
Exclusion Criteria22
- 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
- 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
- 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
- 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, thyroid dysfunction, immunological diseases, malignancy, or any congenital disorder or other diseases which could impede compliance with the study protocol
- 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.
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Interventions
Prototypes for nutritional interventions that are composed of locally available, affordable, culturally acceptable complementary foods commonly consumed in Bangladesh have recently been developed.
RUSF-BEP is composed of rice, lentil, sugar, soybean oil, and skimmed milk powder mixed with vitamin-mineral premix. MD-BEP is composed of chickpea flour, peanut flour, soy flour, green banana pulp, sugar, soybean oil, and vitamin-mineral premix. The results from previous studies support the notion that repair of impaired gut microbial community development could represent a new therapeutic concept for restoring healthy growth. RUSF-BEP will be given to one arm of low-BMI women of reproductive age and low-BMI pregnant women.
Aim 1A consists of performing EGD to women with low-BMI and normal BMI women with function dyspepsia. In order to enroll 30 participants with normal duodenal mucosal histology, we are planning to perform EGD on 100 healthy women (BMI 20-24.9 kg/m2) of childbearing age who have been referred for evaluation of functional dyspepsia. Undernourished low-BMI (\<18.5kg/m2; 18-35 years) women of childbearing age will be enrolled from Bauniabadh and adjacent slum area of Mirpur, Dhaka and EGD will be performed among 60 women. A total of 6-8 biopsy samples from SI and a dry duodenal aspirate will be collected for biopsy, histochemical and immunocytochemical analysis.
Normal BMI pregnant women will be counseled and followed up as per standard guidelines and will be provided routine antenatal care.
Locations(1)
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NCT05862363