Environmental enteropathy
Conditions
Interventions
AA+MM
Unaffected control
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in plasma markers of microbial translocation in HIV seronegative participants, before and after supplementation according to treatment allocation.;Change in tight junction structure (by immunohistochemistry) in HIV seronegative participants, before and after supplementation according to treatment allocation.;Change in metabonomic and microbiome profile in HIV seronegative participants, before and after supplementation according to treatment allocation.;Change in small intestinal absorption and permeability in HIV seronegative participants, before and after supplementation according to treatment allocation.;Change in anthropometry and body composition before and after supplementation according to treatment allocation.;Change in plasma amino acid and micronutrient levels in HIV seronegative participants before and after supplementation, according to treatment allocation.;Chang in mucosal antimicrobial peptide expression in HIV seronegative participants, before and after supplementation according to treatment allocation.;All primary and secondary outcomes will be assessed in HIV seropositive participants;Assessment of interaction between AA and MM interventions;Differences in measured outcome variables between partticipants with and without environmental enteropathy (baseline comparisons). | — |
Countries
Zambia
Contacts
Public ContactJohn Louis-Auguste
Clinical Research Fellow
Outcome results
None listed