Investigating gut health and nutrition in malnourished Bangladeshi women
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)
This study is testing how gut health affects malnourished women in Bangladesh and whether a special nutrition plan can improve their health during pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh Academic / other |
| Locations | 1 site (Dhaka, Dhaka Division) |
| Trial ID | NCT05862363 on ClinicalTrials.gov |
What this trial studies
This study focuses on understanding the role of gut microbiota in Environmental Enteric Dysfunction (EED) among malnourished women of reproductive age in Bangladesh. It involves a comparative assessment of the microbiomes and proteomes of low and normal BMI women, followed by an intervention using microbiota-directed balanced energy protein (MD-BEP) for pregnant women with low BMI. The study aims to identify potential biomarkers for EED and evaluate the effects of nutritional interventions on gut health and overall physiological state. Participants will undergo endoscopic evaluations and provide biological samples throughout the study.
Who should consider this trial
Good fit: Ideal candidates include Bangladeshi women aged 18-35 with a BMI of less than 18.5 kg/m2 or normal BMI between 20-24.9 kg/m2, who are willing to participate in the study.
Not a fit: Patients who are not Bangladeshi women or those with a BMI outside the specified ranges may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional interventions for malnourished women, enhancing their health and that of their children.
How similar studies have performed: Other studies have shown promise in understanding gut microbiota's role in malnutrition, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dhaka, Dhaka Division
- International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) — Dhaka, Dhaka Division, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Md. Shabab Hossain, MBBS — International Centre for Diarrhoeal Disease Research, Bangladesh
- Study coordinator: M. A. Salam Khan
- Email: salamk@icddrb.org
- Phone: +880-2-9827001-10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.