AMAZE 2

The efficacy of amino acid supplementation in treating Zambian children with Environmental Enteropathy and stunting

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202406819114423

Enrollment

Registered

2024-06-20

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System

Interventions

Essential Amino Acid Supplementation

Non stunted control group

Standard care group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Potential participants will be eligible for inclusion if they: • are resident in Misisi, where EE is ubiquitous • are 18-36 months old • have severe stunting (LAZ < -3) • are of either sex • have parents able and willing to undergo HIV testing • have parent, carer or guardian able and willing to give written, informed consent

Exclusion criteria

Exclusion criteria: Potential participants will not be eligible for inclusion if they: • HIV infection (infected children will be recruited and undergo all study procedures, but will not count towards sample size) • Severe wasting (WHZ or WLZ <-3) • Diarrhoea (by mother’s report) in the preceding month • Any contra-indications to endoscopy, including bleeding diathesis • Children with malignancy, allergy, or other condition which, in the opinion of the investigators, would make study participation difficult.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the change in the L/R ratio from baseline to endline. Because L/R ratios are generally not normally distributed, we will use the nonparametric Wilcoxon rank-sum test to compare between the supplementation and control groups within each site. For combined analyses we will use logistic regression models (outcome: L/R ratio above v. below EE cut-off, exposure: intervention or control group).	—

Measure

Time frame

The primary outcome is the change in the L/R ratio from baseline to endline. Because L/R ratios are generally not normally distributed, we will use the nonparametric Wilcoxon rank-sum test to compare between the supplementation and control groups within each site. For combined analyses we will use logistic regression models (outcome: L/R ratio above v. below EE cut-off, exposure: intervention or control group).

—

Secondary

Measure	Time frame
The secondary outcomes are the 1) 13C-SBT, 2) DSIT, 3) biomarkers of inflammation, microbial translocation, and epithelial damage; 4) Weight-for-Age Z score (WAZ), 5) Mucosal morphometry, 6) nitric oxide synthesis, and 7) immune and epithelial cell function. We will use the nonparametric Wilcoxon rank-sum test to compare between the supplementation and control groups within each site. For combined analyses we will use linear regression models or logistic regression models or GEE models based on appropriate cut-off values.	—

Measure

Time frame

The secondary outcomes are the 1) 13C-SBT, 2) DSIT, 3) biomarkers of inflammation, microbial translocation, and epithelial damage; 4) Weight-for-Age Z score (WAZ), 5) Mucosal morphometry, 6) nitric oxide synthesis, and 7) immune and epithelial cell function. We will use the nonparametric Wilcoxon rank-sum test to compare between the supplementation and control groups within each site. For combined analyses we will use linear regression models or logistic regression models or GEE models based on appropriate cut-off values.

—

Countries

Zambia

Contacts

Public ContactMilika Sakala

Administrator

milika@tropgan.com+260977608608

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026