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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Teduglutide 0.05 dose

Treatment groups

55 Participants
are divided into 1 treatment group

Locations

This trial has no locations