A Phase 2 interventional study of Teduglutide 0.05 dose in Environmental Enteric Dysfunction, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Not yet recruiting. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Phase 2, Interventional, and Treatment
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:
Participants will:
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.
260 studies on the registry are indexed under Intestinal Diseases; 53 are open to participants now.
This study's planned enrollment of 55 is below the median of 67 across 180 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 206 studies on the registry; 31 are open to participants now.
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Bangladeshi women, aged 18-35 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sub-cutaneous Teduglutide treatment (0.05 mg/kg/day)
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
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.
Time frame: Baseline and 30 days after teduglutide treatment
No study locations are listed for this record.
Plan to share: Undecided — It is undecided whether individual participant data (IPD) will be shared because the study is a small pilot trial, and plans for data sharing will be determined after study completion, considering participant privacy and consent.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Oct 2027, 15 months later.
Of 14 phase 2 interventional studies under Intestinal Diseases, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 31. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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