AMAZE

Not Applicable

• Conditions: Environmental enteropathy

• Registration Number: PACTR201505001104412
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Intervention arms (environmental enteropathy participants):
Age between 18 and 60 years
Resident in B section, Misisi compound
Able to give informed consent

Unaffected control group:
Age between 18 and 60 years
Able to give informed consent
Household has running water, plumbed indoor toilet and electricity
Household owns a vehicle and television
In full-time education or full-time employment
Resident in Woodlands, Kabulonga, Leopard¿s Hill, Ibex Hill, Longacres, Kalundu or other affluent suburb
Already referred for diagnostic upper GI endoscopy indicated as part of standard clinical care

Exclusion Criteria

Pregnancy (by self-report)
Breast feeding (by self-report)
Antibiotic use within previous 4 weeks
Regular NSAID use within previous 4 weeks
Diarrhoea within previous 4 weeks
Significant comorbidity precluding endoscopy with sedation
Therapeutic anticoagulation or bleeding diathesis precluding endoscopic biopsies
Unwilling to undergo HIV testing
Untreated helminth infection
BMI < 18
Unwilling to consent to long-term storage of samples

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in intestinal structure (by confocal laser endomicroscopy score and morphometry) in HIV seronegative participants before and after supplementation, according to treatment allocation.;Change in mucosal T cell mTOR activity in HIV seronegative participants before and after supplementation, according to treatment allocation.