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Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)

Study acronym: GAME
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07537686
Lead Sponsor International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions
(from sponsor)
Environmental Enteric Dysfunction
Related terms Intestinal Diseases, Malnutrition
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov