Environmental Enteric DysfunctionIAA-EEDNCT07256028
Indispensable Amino Acids Bioavailability in Children With Environmental Enteropathy Dysfunction (IAA-EED)
A study testing Indispensable amino acids supplemntation and Without Indispensable amino acids supplementation in people with Environmental Enteric Dysfunction, run by Morocco's National Centre for Energy, Sciences and Nuclear Techniques at 1 site in Morocco.
Trial summary
In Morocco, large efforts have been made to enhance nutritional status and health conditions of children. Accordingly, stunting was reduced and the prevalence of stunting have decreased from 28,6% in 1987 to 14,9% in 2011. Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Environmental Enteric Dysfunction
- What is being tested?
- Indispensable amino acids supplemntation and Without Indispensable amino acids supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMorocco
- Study dates
- 10 Dec 2025to 31 Jul 2026
- Phase
- Interventional
- 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 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Stunting estimated at least - 2 z score height -for-age
- Abnormal intestinal morphology on jejunal biopsy showing features for EED:
- mucosal inflammation,
- villous blunting
- altered barrier integrity
Who cannot join
- Celiac disease
- Presence of anti-tissue transglutaminase antibodies.
- Primary immunodeficiency disorders
- Inflammatory bowel disease
- Intestinal inflammation food allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Morocco1 site
department of Pediatric Hepatology Gastroenterology and Nutrition-P III. Children's hospital of Rabat - the Ibn Sina University Hospital Center
Rabat, Rabat, 10001
Toufik Meskini, Professor, 0661412241, t.meskini@gmail.com
Mariam Akhrif, MD, +212642536361, akhrif2510@gmail.com
About this study
Official title: Use of Stable Isotopic Dilution to Assess the Bioavailability of Indispensable Amino Acids in Children With Environmental Enteropathy Dysfunction (IAA-EED)
In Morocco, large efforts have been made to enhance nutritional status and health conditions of children. Accordingly, stunting was reduced and the prevalence of stunting have decreased from 28,6% in 1987 to 14,9% in 2011. Many factors, including improved nutrition, have influenced this decrease, and are reinforced to maintain this low prevalence of stunting. Of interest, quality diet, specifically with reference to its protein quality, has contributed to improve the nutritional status of the Moroccan population. However, infectious diseases are still important and in some areas many children are of high risk to develop EED that alter intestinal permeability and microbial translocation, and lead to systemic inflammation. During childhood, protein supply is of a great interest and indigestibility of these proteins and/or malabsorption of indispensable amino acids will affect children growth and many physiological and cognitive functions. This project was planned to assess indispensable amino acids during EED and to to assess the impact of some interventions (amino acids supplementation / medical treatment) on the nutritional status of children.
This study will be carried out according to a trilogy of close collaboration between CNESTEN, Pr Claire Gaudichon from AgroParisTech (France) who will provide technical assistance and scientific accompaniment during the progress of the project, she will also participate in the data analysis, exploitation and valorization of results and the department of Pediatric Hepatology Gastroenterology and Nutrition-P III at the Children's Hospital in Rabat.
Read the detailed description
The investigators will conduct a randomized controlled trial to determine if indispensable amino acid (IAA) supplementation can improve intestinal barrier dysfunction in Moroccan patients aged 18-36-month-old with stunting or severe stunting. The primary endpoint will be change in gut permeability as assessed by the lactulose/rhamnose (LR) ratio, while secondary endpoint will focus on change in amino acid absorption using an isotope tracer test. IAA supplementation will be given daily for 28 days, and evaluation of the major endpoints will be at baseline and 28 days
- Conditions
- Environmental Enteric Dysfunction
- Being tested
- Indispensable amino acids supplemntation, Without Indispensable amino acids supplementation
- Keywords
- Indispensable amino acids, Environmental enteric dysfunction, bioavailability, amino acids supplementatuion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indispensable amino acids supplemntationDietary supplement
18-36-month-old children in the intervention arm will receive milk with IAA supplementation for 28 days, while children in the control group will receive only milk for the same duration
Without Indispensable amino acids supplementationDietary supplement
Also called IAA supplemntation
18-36-month-old children in the intervention arm will receive milk with IAA supplementation for 28 days, while children in the control group will receive milk without IAA during the same duration
| Study group | Role | What they receive |
|---|---|---|
| Arm with IAA supplemntation | Experimental | 18-36-month-old children will receive daily 100 ml of milk supplemented with IAA Receives: Dietary Supplement: Indispensable amino acids supplemntation |
| Arm without IAA supplementation | Experimental | 18-36 months-aged children will receive only milk Receives: Dietary Supplement: Without Indispensable amino acids supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of the lactulose/rhamnose (LR) ratio to assess improvement in gut permeability among stunted Moroccan children aged 18-36 months after 28 days of Indispensable Amino Acids (IAA) supplementation.
The purpose of this measure is to assess gut permeability efficiency and whether supplementation with IAA can improve it. In fact, the lactulose/rhamnose (LR) ratio or the dual-sugar test is a non-invasive test used to measure intestinal permeability. It works by orally administering of two inert sugar molecules, lactulose and rhamnose, then measuring their excretion in urine; a higher LR ratio suggests increased intestinal permeability, often indicating damage to the gut lining. This test is useful in research and clinical settings for assessing conditions that affect the small intestine.
Measured: The procedure involves assessing gut permeability at enrolment and again after 28 days of IAA supplementation.
Use of Dual-Stable Isotope Test (DSIT) to assess improvement of the true ileal bioavailability of IAA among stunted Moroccan children aged 18-36 months after 28 days of IAA supplementation.
The purpose of this measure is to assess the rate of IAA bioavailability and determine whether IAA supplementation can improve it. To this end, the Dual-Stable Isotope Test (DSIT) will be used. The DSIT is a minimally invasive method for measuring the true ileal bioavailability of IAAs in humans, using a meal containing both the 2H-labeled test protein and the 13C-labeled reference protein. In this study, children will consume a test meal (milk) containing both the 2H-AA mix (1.25 mg/kg body weight) and the U-13C spirulina (10 mg/kg body weight). To carry out this technique, two blood (plasma) samples will be collected, one before the meal is administrated and the second 5hours after afterwards. A portion of the meal will be frozen at -80°C for later analysis of the two isotopes. The bioavailability of each IAA is calculated by comparing the ratio of the two isotopes in the plasma samples to their ratio in the original test meal.
Measured: The procedure involves assessing the rate of IAA bioavailability at enrolment and again after 28 days of IAA supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 18-36-month-old children in the intervention arm will receive milk with IAA supplementation for 28 days, while children in the control group will receive only milk for the same duration
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morocco's National Centre for Energy, Sciences and Nuclear Techniques
- Sponsor type
- University, hospital or other
- Collaborators
- CCTD, Centre Hospitalier Ibn Sina,Morocco, AgroParisTech
- Responsible party
- Principal investigator, Mohammed El Mzibri, Morocco's National Centre for Energy, Sciences and Nuclear Techniques
- Investigators
- Mohammed El Mzibri, Principal investigator, Centre National de l'Energie, des Sciences et des Techniques NucléaireToufik Meskini, Professor, Study director, Department of Pediatric Hepatology Gastroenterology and Nutrition-P III. Children's hospital of Rabat - the Ibn Sina University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256028
- Sponsor's protocol ID
- IAEA Research Contract 24437
- Acronym
- IAA-EED
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only scientific results will be published
Publications
Lee GO, Owino V, Baquiran AFP, Pasanna RM, Achoribo SE, Meskini T, Amadi B, Maleta KM, Gaudichon C, Serafico ME, Hegde S, Cabanilla CVD, Devi S, El Mzibri M, Brouwer AF, Kurpad AV, Kelly P, Morrison D. Impact of indispensable amino acid supplementation on gut function in children at high risk of environmental enteropathy: protocol for an international coordinated group of randomised controlled trials. BMJ Open. 2026 Apr 24;16(4):e105456. doi: 10.1136/bmjopen-2025-105456.
PubMed 42031499
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Stable Isotopic Dilution to Assess the Bioavailability of Indispensable Amino Acids in Children With Environmental Enteropathy Dysfunction (IAA-EED)
- ClinicalTrials.gov ID
- NCT07256028
- Acronym / sponsor ID
- IAA-EED / IAEA Research Contract 24437
- Conditions
- Environmental Enteric Dysfunction
- Keywords
- Indispensable amino acids, Environmental enteric dysfunction, bioavailability, amino acids supplementatuion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Morocco's National Centre for Energy, Sciences and Nuclear TechniquesUniversity, hospital or other
- Collaborators
- CCTD, Centre Hospitalier Ibn Sina,Morocco, AgroParisTech
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Dec 2025 (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.
In Morocco, large efforts have been made to enhance nutritional status and health conditions of children. Accordingly, stunting was reduced and the prevalence of stunting have decreased from 28,6% in 1987 to 14,9% in 2011. Many factors, including improved nutrition, have influenced this decrease, and are reinforced to maintain this low prevalence of stunting. Of interest, quality diet, specifically with reference to its protein quality, has contributed to improve the nutritional status of the Moroccan population. However, infectious diseases are still important and in some areas many children are of high risk to develop EED that alter intestinal permeability and microbial translocation, and lead to systemic inflammation. During childhood, protein supply is of a great interest and indigestibility of these proteins and/or malabsorption of indispensable amino acids will affect children growth and many physiological and cognitive functions. This project was planned to assess indispensable amino acids during EED and to to assess the impact of some interventions (amino acids supplementation / medical treatment) on the nutritional status of children.
This study will be carried out according to a trilogy of close collaboration between CNESTEN, Pr Claire Gaudichon from AgroParisTech (France) who will provide technical assistance and scientific accompaniment during the progress of the project, she will also participate in the data analysis, exploitation and valorization of results and the department of Pediatric Hepatology Gastroenterology and Nutrition-P III at the Children's Hospital in Rabat.
Detailed description
The investigators will conduct a randomized controlled trial to determine if indispensable amino acid (IAA) supplementation can improve intestinal barrier dysfunction in Moroccan patients aged 18-36-month-old with stunting or severe stunting. The primary endpoint will be change in gut permeability as assessed by the lactulose/rhamnose (LR) ratio, while secondary endpoint will focus on change in amino acid absorption using an isotope tracer test. IAA supplementation will be given daily for 28 days, and evaluation of the major endpoints will be at baseline and 28 days
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The 18-36-month-old children in the intervention arm will receive milk with IAA supplementation for 28 days, while children in the control group will receive only milk for the same duration
| Arm | Type | Receives |
|---|---|---|
| Arm with IAA supplemntation | Experimental | Dietary Supplement: Indispensable amino acids supplemntation18-36-month-old children will receive daily 100 ml of milk supplemented with IAA |
| Arm without IAA supplementation | Experimental | Dietary Supplement: Without Indispensable amino acids supplementation18-36 months-aged children will receive only milk |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Stunting estimated at least - 2 z score height -for-age
- Abnormal intestinal morphology on jejunal biopsy showing features for EED:
- mucosal inflammation,
- villous blunting
- altered barrier integrity
Key exclusion criteria (5 listed)
- Celiac disease
- Presence of anti-tissue transglutaminase antibodies.
- Primary immunodeficiency disorders
- Inflammatory bowel disease
- Intestinal inflammation food allergy
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 |
|---|---|---|
| Indispensable amino acids supplemntation18-36-month-old children in the intervention arm will receive milk with IAA supplementation for 28 days, while children in the control group will receive only milk for the same duration | Dietary supplement | Arm with IAA supplemntation |
| Without Indispensable amino acids supplementationAlso: IAA supplemntation18-36-month-old children in the intervention arm will receive milk with IAA supplementation for 28 days, while children in the control group will receive milk without IAA during the same duration | Dietary supplement | Arm without IAA supplementation |
Primary outcome
Use of the lactulose/rhamnose (LR) ratio to assess improvement in gut permeability among stunted Moroccan children aged 18-36 months after 28 days of Indispensable Amino Acids (IAA) supplementation.
Time frame: The procedure involves assessing gut permeability at enrolment and again after 28 days of IAA supplementation.
The purpose of this measure is to assess gut permeability efficiency and whether supplementation with IAA can improve it. In fact, the lactulose/rhamnose (LR) ratio or the dual-sugar test is a non-invasive test used to measure intestinal permeability. It works by orally administering of two inert sugar molecules, lactulose and rhamnose, then measuring their excretion in urine; a higher LR ratio suggests increased intestinal permeability, often indicating damage to the gut lining. This test is useful in research and clinical settings for assessing conditions that affect the small intestine.
Use of Dual-Stable Isotope Test (DSIT) to assess improvement of the true ileal bioavailability of IAA among stunted Moroccan children aged 18-36 months after 28 days of IAA supplementation.
Time frame: The procedure involves assessing the rate of IAA bioavailability at enrolment and again after 28 days of IAA supplementation.
The purpose of this measure is to assess the rate of IAA bioavailability and determine whether IAA supplementation can improve it. To this end, the Dual-Stable Isotope Test (DSIT) will be used. The DSIT is a minimally invasive method for measuring the true ileal bioavailability of IAAs in humans, using a meal containing both the 2H-labeled test protein and the 13C-labeled reference protein. In this study, children will consume a test meal (milk) containing both the 2H-AA mix (1.25 mg/kg body weight) and the U-13C spirulina (10 mg/kg body weight). To carry out this technique, two blood (plasma) samples will be collected, one before the meal is administrated and the second 5hours after afterwards. A portion of the meal will be frozen at -80°C for later analysis of the two isotopes. The bioavailability of each IAA is calculated by comparing the ratio of the two isotopes in the plasma samples to their ratio in the original test meal.
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 1 Dec 2025.
- Derived from this study: PubMed 42031499Lee GO, Owino V, Baquiran AFP, Pasanna RM, Achoribo SE, Meskini T, Amadi B, Maleta KM, Gaudichon C, Serafico ME, Hegde S, Cabanilla CVD, Devi S, El Mzibri M, Brouwer AF, Kurpad AV, Kelly P, Morrison D. Impact of indispensable amino acid supplementation on gut function in children at high risk of environmental enteropathy: protocol for an international coordinated group of randomised controlled trials. BMJ Open. 2026 Apr 24;16(4):e105456. doi: 10.1136/bmjopen-2025-105456.
- Individual participant dataSharing planned: No. Only scientific results will be published
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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.
Mohammed El Mzibri principal investigator
Centre National de l'Energie, des Sciences et des Techniques Nucléaire
Toufik Meskini, Professor study director
Department of Pediatric Hepatology Gastroenterology and Nutrition-P III. Children's hospital of Rabat - the Ibn Sina University Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indispensable amino acids supplemntation and Without Indispensable amino acids supplementation in people with Environmental Enteric Dysfunction, run by Morocco's National Centre for Energy, Sciences and Nuclear Techniques at 1 site in Morocco.
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 5 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 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Mohammed El Mzibri, PhD (+212661479124, mzibri@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of the lactulose/rhamnose (LR) ratio to assess improvement in gut permeability among stunted Moroccan children aged 18-36 months after 28 days of Indispensable Amino Acids (IAA) supplementation. (time frame: The procedure involves assessing gut permeability at enrolment and again after 28 days of IAA supplementation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07256028, which also lists 1 linked publication.
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 1 Dec 2025.