The Maternal EED Study

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · May 7, 2023

Keywords

ClinConnect Summary

The Maternal EED Study is a research trial aimed at understanding how gut bacteria may impact malnutrition, specifically in women of reproductive age living in South Asia. This study is particularly focused on women who are pregnant and have a low body mass index (BMI) of less than 18.5. It aims to see how different nutritional supplements can help improve their health during pregnancy and after giving birth. The participants will be divided into two groups: one will receive a special nutritional supplement designed to support gut health, while the other will receive a ready-to-eat food supplement. There will also be a control group of normal-BMI pregnant women who will not receive any extra nutritional support.

To participate in the trial, women must be Bangladeshi, aged between 18 and 35, and meet specific health criteria, such as being underweight or having a normal BMI. Participants can expect to receive standard prenatal care, along with the nutritional supplements, and will need to provide biological samples and undergo some medical procedures during the study. This trial is important because it seeks to address the high rates of malnutrition among women in South Asia, which can affect both their health and the health of their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Inclusion criteria for pregnant low-BMI women
• • 1. Bangladeshi female, age 18-35 years
• • 2. BMI 20-24.9 kg/m2
• • 3. Middle-upper socioeconomic class (≥ $11/day family income)
• • 4. Functional dyspepsia
• • 5. Willing to sign the consent form
• • 6. Willing to provide biological samples during the study period of 6 months
• • Inclusion criteria for non-pregnant low-BMI women 1. Bangladeshi female, age 18-35 years
• • 1. BMI \<18.5 kg/m2
• • 2. No antibiotics for 1 month
• • 3. Willing to sign the consent form
• • 4. Willing to undergo endoscopy and biopsy
• • 5. Willing to provide biological samples during the study period of 6 months
• • 6. Willing to receive food supplementation for 3 months
• • Inclusion criteria for normal-BMI non-pregnant women
• • 1. Bangladeshi female, age 18-35 years
• • 2. BMI 20-24.9 kg/m2
• • 3. Middle-upper socioeconomic class (≥ $11/day family income)
• • 4. Functional dyspepsia
• • 5. Willing to sign the consent form
• • 6. Willing to provide biological samples during the study period of 6 months
• • Inclusion criteria for normal-BMI pregnant women
• • 1. Bangladeshi female, age 18-35 years
• • 2. BMI 20-24.9 kg/m2
• • 3. Middle-upper socio-economic class (≥ $11/day family income)
• • 4. Enrolled at the end of first-trimester of pregnancy (before 14 weeks of gestation)
• • 5. Willing to sign the consent form
• • 6. Willing to undergo endoscopy and biopsy
• • 7. Willing to provide biological samples during the study period
• • 8. Willing to let anthropometry and biological sample collection from her newborn for the first 6 months of life
• Exclusion Criteria:
• • Exclusion criteria for pregnant low-BMI women
• • 1. Received antibiotics during the last one month
• • 2. Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity
• • 3. 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
• • 1. Severe anemia (\<8 g/dl), TB and other chronic diseases, including diabetes mellitus, urogenital infections or any congenital disorder or deformity
• • 2. Pregnancy, lactation, drug abuse, known psychiatric disorders
• 3. 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 undergo following screening tests based on clinical judgement:
• • 1. Chest x-ray
• • 2. Urine for R/E
• • 3. Ultrasonography of whole abdomen
• • 4. Fasting blood glucose/ HbA1c
• • 5. Stool for OBT (occult blood test)
• • 6. Cancer markers (ie. CEA, CA 15.3, CA 19.9)
• • 4. Known allergy to any components of nutrition intervention
• • 5. 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.
• • 6. 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
• • 1. Received antibiotics during the last one month
• • 2. Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity
• • 3. 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
• • 1. Multiple pregnancy (carrying two or more fetuses)
• • 2. Threatened abortion, persistent pervaginal bleeding, or cervical incompetence
• • 3. History of three or more consecutive abortions
• • 4. History of gestational diabetes, macrosomia, gestational hypertension, preeclampsia/eclampsia in a prior pregnancy
• • 5. Active disease/complications requiring acute phase treatment in a hospital
• • 6. Tuberculosis
• • 7. Severe anemia (Hb concentration \< 8 mg/dl)
• • 8. Antibiotic use (ongoing or within last two weeks before the onset of intervention)
• • 9. Taking medications such as insulin, thyroid hormones, glucocorticoids
• • 10. 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
• • 11. Known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder
• • 12. Having known history of allergy to the therapeutic agents
• • 13. Having a plan to move or deliver outside the study area
• • 14. Known allergy to any components of nutrition intervention.