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

Not Applicable

Not yet recruiting

• Conditions: Amino Acid, Stunting, Environmental Enteric Dysfunction
• Interventions: Dietary Supplement: Corn soy bean blended flour porridge plus indispensable amino acid

• Registration Number: NCT06617130
• Lead Sponsor: Kamuzu University of Health Sciences

Brief 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 months with or without stunting.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-09-27
• Last Update Posted: 2024-09-27
• Study Start: 2024-11-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 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:

1. 18-36 months old (now agreed to by all countries)
2. Stunted (LAZ<-2)
3. Of either sex
4. Able and willing to undergo HIV testing
5. Parent, carer, or guardian able and willing to give written, informed consent
6. A positive HIV test result will not be an exclusion criterion.

Exclusion Criteria

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

  1. Under 18 months of age
  2. Over 36 months old
  3. Wasted (weight-for-length Z-score less than -2)
  4. Overweight (weight-for-length Z-score greater than 2)
  5. Have had diarrhea (by self-report) in the preceding month
  6. Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
  7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corn soy bean flour porridge with added indespensable amino acids	Corn soy bean blended flour porridge plus indispensable amino acid	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.
Corn soy bean flour porridge	Corn soy bean blended flour porridge plus indispensable amino acid	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.

Primary Outcome Measures

Name	Time	Method
corn soy bean flour porridge with added indespensable amino acids	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.

Secondary Outcome Measures

Name	Time	Method
Corn soy bean flour porridge	30 days	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

Trial Locations

Locations (1)

Kamuzu University of Health Sciences; 🇲🇼 Blantyre, Malawi