Environmental Enteric DysfunctionPhase 2GAMENCT07537686
Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
A Phase 2 study testing Teduglutide 0.05 dose in people with Environmental Enteric Dysfunction, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Environmental Enteric Dysfunction
- What is being tested?
- Teduglutide 0.05 dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Environmental Enteric Dysfunction
- Being tested
- Teduglutide 0.05 dose
- Keywords
- Enteropathy, Environmental enteric dysfunction, Teduglutide, Undernutrition, Women, intestinal biopsy
- Medical subject headings
- Intestinal Diseases, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teduglutide 0.05 doseDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Teduglutide Treatment Arm | Experimental | Sub-cutaneous Teduglutide treatment (0.05 mg/kg/day) Receives: Drug: Teduglutide 0.05 dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 30 days after teduglutide treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental Enteric DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537686
- Sponsor's protocol ID
- PR-25002
- Acronym
- GAME
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
- ClinicalTrials.gov ID
- NCT07537686
- Acronym / sponsor ID
- GAME / PR-25002
- Conditions
- Environmental Enteric Dysfunction
- Keywords
- Enteropathy, Environmental enteric dysfunction, Teduglutide, Undernutrition, Women, intestinal biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teduglutide Treatment Arm | Experimental | Drug: Teduglutide 0.05 doseSub-cutaneous Teduglutide treatment (0.05 mg/kg/day) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Teduglutide Treatment Arm |
Primary outcome
Composite EED (Environmental Enteric Dysfunction) Histopathologic Score
Time frame: Baseline and 30 days after teduglutide treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teduglutide 0.05 dose in people with Environmental Enteric Dysfunction, run by International Centre for Diarrhoeal Disease Research, Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Mahfuz, PhD (+8801712214205, mustafa@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite EED (Environmental Enteric Dysfunction) Histopathologic Score (time frame: Baseline and 30 days after teduglutide treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.