Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teduglutide 0.05 dose.
- Who it may be relevant to
- Registry conditions: Environmental Enteric Dysfunction. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Background:
Burden: Recent studies indicated an association between undernutrition and Environmental Enteric Dysfunction (EED) with more than 90% of undernourished women in Dhaka slum having histo-pathological evidence of EED.
Knowledge gap: Currently, there is no available treatment for this condition. Teduglutide, a glucagon-like peptide-2 (GLP-2) analog, has been shown to improve damaged intestinal mucosa, improve villi height, absorptive capacity, and reduce mucosal inflammation. A recent study among children in Zambia and Zimbabwe with malnutrition enteropathy demonstrated significant improvement of EED features with no adverse effect following teduglutide treatment.
Relevance: Given the fundamental structural and functional alterations of the intestine due to EED, GLP-2 analogues such as teduglutide could significantly revolutionize treatment strategies. However, teduglutide has not yet been trialed in adults with EED.
Hypothesis: Daily treatment Glucagon-like Peptide 2 (GLP-2) Analog teduglutide for thirty days will improve histologic and biomarkers features of EED in undernourished women with biopsy-proven EED.
Objectives: To examine the efficacy of daily sub-cutaneous glucagon-like peptide 2 (GLP-2) analog teduglutide treatment for 30 days in undernourished women with histology-confirmed EED on improving histology features of EED (a continuous score on villus height, crypt depth, and immune infiltration) (Primary objective) and biomarkers of inflammation, intestinal permeability, enterocyte mass, and absorption (secondary objectives).
Methods: This is a community-based, single-arm, open-label, pilot intervention study. Undernourished women aged 18-35 years with a Body Mass Index (BMI) between 16 to 18.5 kg/m² will be enrolled from Bauniabadh and adjacent slum areas in Mirpur, Dhaka. Initially, participants will participate in a 60-day on-site nutrition intervention consisting of one egg (boiled or fried), 150 mL milk, two chapati/flat bread/bread with vegetable/lentil soup, and one tablet containing the 15-component UNIMMAP MMS (FullCare, SMC, Dhaka). Participants who do not respond adequately to this intervention (BMI \< 18.5 and at least 10% improvement of baseline BMI) and who will not have any secondary causes of malnutrition will undergo an upper gastrointestinal (UGI) endoscopy and histologic evaluation for EED. Participants with histology-confirmed EED, who will provide consent will receive daily sub-cutaneous teduglutide (0.05 mg/kg/day) treatment for 30 days. A second UGI endoscopy will be done after the endoscopy and the biomarkers will assessed at different time points.
Sample Size: 55 participants will receive teduglutide treatment and at least 30 undernourished women with histology-confirmed EED will complete the study. To identify women with EED with a rationale to perform UGI endoscopies, and expected drop outs, we will enroll 500 low-BMI women for nutrition intervention. An additional 30 normal-BMI (20-24.9 kg/m² will be enrolled for aminoacid absorption studies.
Primary end point: A continuous measure, based on the presence of established histopathologic indicators of EED, including immune cell infiltration, reduced villus height, and increased crypt depth. Each feature present will contribute one point to the composite score, resulting in a total EED score ranging from 0 to 7 for participants undergoing EGD. A higher score indicates the presence of more severe EED.
Secondary end point: Histological recovery from EED, as indicated by reduced infiltration of immune cells, increased villus height, and reduced crypt depth. Recovery from EED will be assessed using a four-level ordinal outcome scale, ("no EED," "mild EED," "moderate EED," and "severe EED") at baseline and after treatment.
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
Primary outcome measures
- Composite EED (Environmental Enteric Dysfunction) Histopathologic Score [Time frame: Baseline and 30 days after teduglutide treatment]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07537686 · PR-25002