CompletedNot Applicable

Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh

Bangladesh20 participantsStarted 2022-07-18

Plain-language summary

This is a pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on efficacy will also be obtained.

Who can participate

Age range1 Year – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Length-for-age Z score (LAZ) between -1 and -3 standard deviations * Lactulose mannitol ratio \>0.09 Exclusion Criteria: * Presence of known congenital or chronic diseases other than malnutrition * Diarrhea (\> 3 unformed stools in a 24-hour window) in the 7 days prior to screening * Anticipated unavailability for study visits * A sibling previously enrolled in this study

What they're measuring

Change in appetite

Timeframe: Baseline to 14 days

Change in gastrointestinal health

Timeframe: Baseline to 14 days

Change in 2 hour Lactulose mannitol ratio

Timeframe: Baseline to 14 days

Trial details

NCT IDNCT05291559

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-07

View on ClinicalTrials.gov More Environmental Enteric Dysfunction trials