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NOT YET RECRUITING
NCT07537686
PHASE2

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

Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2026-07-01

Completion Date

2027-12-30

Last Updated

2026-04-17

Healthy Volunteers

No

Interventions

DRUG

Teduglutide 0.05 dose

* 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