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

NCT07537686 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PR-25002
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Environmental Enteric Dysfunction

Keywords

Enteropathy; Environmental enteric dysfunction; Teduglutide; Undernutrition; Women; intestinal biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 30 days after teduglutide treatment

Study Arms (1)

Teduglutide Treatment Arm

EXPERIMENTAL

Sub-cutaneous Teduglutide treatment (0.05 mg/kg/day)

Drug: Teduglutide 0.05 dose

Interventions

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

Teduglutide Treatment Arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Bangladeshi women, aged 18-35 years
• 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
• Willing to receive daily one-month sub-cutaneous GLP 2 analog, Teduglutide treatment
• Willing to undergo endoscopy and biopsy, twice, before and after intervention, if failed to respond to nutrition intervention and who did not have other chronic or acute diseases that may cause malnutrition
• Willing to provide biological samples during the study period of 4 months

You may not qualify if:

• 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
• Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

MeSH Terms

Conditions

Intestinal Diseases; Malnutrition

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Mustafa Mahfuz, PhD

CONTACT

+8801712214205; mustafa@icddrb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-01