Amino Acid, Stunting, Environmental Enteric DysfunctionNCT06617130

The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition

A study testing Corn soy bean blended flour porridge plus indispensable amino acid in people with Amino Acid, Stunting, Environmental Enteric Dysfunction, run by Kamuzu University of Health Sciences at 1 site in Malawi.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

A randomised controlled open label clinical trial to determine whether addition of indispensable amino acids (IAA) to standard complementary food will reduce occurrence of Environmental Enteric Dysfunction (EED) compared with provision of standard complementary food without IAA in healthy Malawian children aged 18-36… Read more about this study

Who is it for?: Ages 18 to 36 monthsHealthy volunteers can take part
Conditions the study is for: Amino Acid, Stunting, Environmental Enteric Dysfunction
What is being tested?: Corn soy bean blended flour porridge plus indispensable amino acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteMalawi
Study dates: 1 Nov 2024to 1 Dec 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
Healthy volunteers accepted
Child

Who may be able to join

All children identified from the Mangochi DSS whose guardian/parent desires screening will be eligible for screening. This will first include age, weight, length, and MUAC assessment. If a participant meets age and anthropometric criteria, they will be invited to undergo full inclusion/exclusion criteria assessment, consent, and randomization.
In order to be eligible to participate in the study, an individual must meet all of the following criteria:
18-36 months old (now agreed to by all countries)
Stunted (LAZ\<-2)
Of either sex
Able and willing to undergo HIV testing
Parent, carer, or guardian able and willing to give written, informed consent
A positive HIV test result will not be an exclusion criterion.

Who cannot join

An individual who meets any of the following criteria will be excluded from participation in this study:
Under 18 months of age
Over 36 months old
Wasted (weight-for-length Z-score less than -2)
Overweight (weight-for-length Z-score greater than 2)
Have had diarrhea (by self-report) in the preceding month
Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
Have any underlying condition other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Malawi1 site

Kamuzu University of Health Sciences
Blantyre
Kenneth Maleta, PhD, +265 888 232 202, kmaleta@kuhes.ac.mw
Andrew Matchado, PhD, +265 880 205 790, amatchado@kuhes.ac.mw

Other trials in Malawi

About this study

Conditions: Amino Acid, Stunting, Environmental Enteric Dysfunction
Being tested: Corn soy bean blended flour porridge plus indispensable amino acid
Medical subject headings: Growth Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Corn soy bean blended flour porridge plus indispensable amino acidDietary supplement
Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive corn-soy bean blended flour porridge supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) dosed at 12g/d and providing 1.5 times the estimated average requirement (EAR) for a healthy child (Intervention group). The porridge will provide 30% daily energy requirement. The study foods will be taken once daily by the child with at least three observed feeding sessions per week over the 4 weeks of the study to assess compliance.
Children in the control arm will receive corn-soy blended flour porridge without added amino acids.

Study groups in NCT06617130
Study group	Role	What they receive
corn soy bean flour porridge with added indespensable amino acids	Active comparator	Children in the intervention arm will receive corn-soy blended flour porridge mixed with IAA. The CSB flour will be packed in 1kg packets while the IAA will be packed in small plastic bags. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. Pre-weighed IAA will be provided so that mothers can mix the IAA to the prepared CSB porridge. The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day. Receives: Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acid
Corn soy bean flour porridge	Other	Children in the control arm children will receive corn-soy blended flour porridge only. The CSB flour will be packed in 1kg packets. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day. Receives: Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acid

What is being measured

The primary outcome is the main question the study is designed to answer.

corn soy bean flour porridge with added indespensable amino acids
Primary Efficacy Endpoint:
We hypothesize that adding 12mg IAA to corn-soy blended flour porridge provided to Malawian children aged 18-36 months with or without stunting will reduce gut permeability as measured by the Lactulose:Rhamonse ratio test when provided over 30 days compared to corn-soy blended flour porridge without added IAA.
Measured: 30 days

Secondary outcomes (1)

Corn soy bean flour porridge
We hypothesize that adding 12mg IAA to corn-soy blended flour porridge provided to Malawian children aged 18-36 months with or without stunting when provided over 30 days compared to corn-soy blended flour porridge without added IAA will:
1. Increase gut digestive capacity
2. Increase plasma protein absorption
3. Reduce gut bacterial translocation
4. Reduce gut bacterial damage
5. Increase child weight
6. Increase plasma circulating amino acids
7. Increase gut microbial abundance and diversity
8. Increase fat free mass index and fat free percentage
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20241 Dec 2026

First posted27 Sep 2024
Study start1 Nov 2024 (estimated)
Primary completion1 Aug 2026 (estimated)
Study completion1 Dec 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 Amino Acid, Stunting, 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: We hypothesize that adding 12 mg/day of indispensable amino acids (IAA) to corn-soy blend blended flour porridge will reduce gut permeability amongst 6-36 month old rural Malawian children at risk of stunting compared to providing only corn-soy blended flour porridge without addition of indispensable amino acids for a period of 4 weeks. This will be a randomized, controlled open label parallel group efficacy clinical trial. Eligible children will be identified through a Demographic Surveillance System implemented by the study group at Mangochi district hospital. 66 children meeting set criteria will be randomised to receive corn-soy blended flour porridge (control group) or corn-soy blended flour porridge to which is added indispensable amino acids. The standard complementary food will provide 30% daily energy requirement while the amino acids in the intervention group will provide 1.5 times the estimated average requirement (EAR) for a healthy child.
Masking: Single blind
Who is masked: Participant
Enrolment: 66 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06617130
Sponsor's protocol ID: P.02/23/3992
Status last verified: Jun 2024
First submitted: 16 Sep 2024
Last updated: 27 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The Principal Investigator will determine authorship on primary and secondary publications of data derived from this trial and published by the PI's research group. De-identified data will be shared with PI approval beginning 6 months after primary trial publication with researchers that provide reasonable statistical analysis plans.

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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition
ClinicalTrials.gov ID: NCT06617130
Acronym / sponsor ID: P.02/23/3992
Conditions: Amino Acid, Stunting, Environmental Enteric Dysfunction
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 66 participants (estimated)
Lead sponsor: Kamuzu University of Health SciencesUniversity, hospital or other
Collaborators: University of Glasgow
Study start: 1 Nov 2024 (estimated)
Primary completion: 1 Aug 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 27 Sep 2024 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: We hypothesize that adding 12 mg/day of indispensable amino acids (IAA) to corn-soy blend blended flour porridge will reduce gut permeability amongst 6-36 month old rural Malawian children at risk of stunting compared to providing only corn-soy blended flour porridge without addition of indispensable amino acids for a period of 4 weeks. This will be a randomized, controlled open label parallel group efficacy clinical trial. Eligible children will be identified through a Demographic Surveillance System implemented by the study group at Mangochi district hospital. 66 children meeting set criteria will be randomised to receive corn-soy blended flour porridge (control group) or corn-soy blended flour porridge to which is added indispensable amino acids. The standard complementary food will provide 30% daily energy requirement while the amino acids in the intervention group will provide 1.5 times the estimated average requirement (EAR) for a healthy child.

Arm	Type	Receives
corn soy bean flour porridge with added indespensable amino acids	Active comparator	Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acidChildren in the intervention arm will receive corn-soy blended flour porridge mixed with IAA. The CSB flour will be packed in 1kg packets while the IAA will be packed in small plastic bags. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. Pre-weighed IAA will be provided so that mothers can mix the IAA to the prepared CSB porridge. The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.
Corn soy bean flour porridge	Other	Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acidChildren in the control arm children will receive corn-soy blended flour porridge only. The CSB flour will be packed in 1kg packets. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.

Who may qualify

Ages: 18 to 36 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

All children identified from the Mangochi DSS whose guardian/parent desires screening will be eligible for screening. This will first include age, weight, length, and MUAC assessment. If a participant meets age and anthropometric criteria, they will be invited to undergo full inclusion/exclusion criteria assessment, consent, and randomization.
In order to be eligible to participate in the study, an individual must meet all of the following criteria:
18-36 months old (now agreed to by all countries)
Stunted (LAZ\<-2)
Of either sex

Key exclusion criteria (8 listed)

An individual who meets any of the following criteria will be excluded from participation in this study:

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
Corn soy bean blended flour porridge plus indispensable amino acidProtocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive corn-soy bean blended flour porridge supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) dosed at 12g/d and providing 1.5 times the estimated average requirement (EAR) for a healthy child (Intervention group). The porridge will provide 30% daily energy requirement. The study foods will be taken once daily by the child with at least three observed feeding sessions per week over the 4 weeks of the study to assess compliance. Children in the control arm will receive corn-soy blended flour porridge without added amino acids.	Dietary supplement	Corn soy bean flour porridge, corn soy bean flour porridge with added indespensable amino acids

Primary outcome

corn soy bean flour porridge with added indespensable amino acids
Time frame: 30 days
Primary Efficacy Endpoint: We hypothesize that adding 12mg IAA to corn-soy blended flour porridge provided to Malawian children aged 18-36 months with or without stunting will reduce gut permeability as measured by the Lactulose:Rhamonse ratio test when provided over 30 days compared to corn-soy blended flour porridge without added IAA.

1 secondary outcome

Corn soy bean flour porridge
Time frame: 30 days

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 27 Sep 2024.
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: Undecided. The Principal Investigator will determine authorship on primary and secondary publications of data derived from this trial and published by the PI's research group. De-identified data will be shared with PI approval beginning 6 months after primary trial publication with researchers that provide reasonable statistical analysis plans.

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.

Kamuzu University of Health Sciences

Blantyre, Malawi

+265 888 232 202

kmaleta@kuhes.ac.mw

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 27 Sep 2024. 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 Malawi. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

corn soy bean flour porridge with added indespensable amino acids (time frame: 30 days). 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 NCT06617130, 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 27 Sep 2024.