The goal of this clinical trial is to learn whether teduglutide, a medicine that helps the intestine heal, can improve environmental enteric dysfunction in undernourished women aged 18 to 35 years living in urban slums of Dhaka.
Environmental enteric dysfunction is a long-lasting condition of the small intestine. It causes inflammation and poor absorption of nutrients. Many people with this condition do not have clear symptoms, but it can make undernutrition worse. At present, there is no proven treatment for this condition.
The main questions this study aims to answer are:
* Does taking teduglutide for 30 days improve damage to the small intestine, as seen on intestinal biopsy? * Does teduglutide improve blood and stool markers related to gut inflammation and nutrient absorption?
Participants will:
* Receive nutritional support at the start of the study * Undergo an upper gastrointestinal endoscopy to confirm environmental enteric dysfunction * Receive a daily injection of teduglutide under the skin for 30 days * Undergo repeat endoscopy and laboratory tests after treatment to assess changes in gut health The results of this study will help researchers understand whether teduglutide may be a useful treatment for environmental enteric dysfunction in undernourished adult women and will guide future, larger studies.
BMI between 16 kg/m2 to 18.5 kg/m2
No antibiotics for 1 month
Willing to sign the consent form
Willing to receive food and multiple micronutrient supplementation for 2 months
Severe anemia (<8 g/dl), known case of TB, and other chronic diseases, including diabetes mellitus 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.
Known allergy to any components of nutrition intervention or any GI polyp
Single group
Teduglutide 0.05 dose
Drug* 30 days of daily sub-cutaneous Teduglutide treatment (0.05 mg/kg/day) (N= 55) * Monitoring schedule during and after teduglutide treatment * Surveillance visits with a physician: monitoring of adverse events: day 1, day 7, day 15 and day 30 * Biological sample collection for biomarkers: mid-line (day 15), end-line (day-30 or Day 31), and day 90 post-intervention
Composite EED (Environmental Enteric Dysfunction) Histopathologic Score
The primary outcome is the EED score, a continuous measure derived from histomorphological features of the intestinal mucosa obtained through upper gastrointestinal endoscopy (EGD) with mucosal biopsy. The score ranges from 0 to 7, with higher scores indicating more severe intestinal damage. The score will be calculated before treatment and after 30 days of daily subcutaneous teduglutide administration to assess changes in intestinal histology.
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This trial is not recruiting at the moment. You can still explore other options:
