Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedStudy Start
First participant enrolled
July 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2022
CompletedSeptember 10, 2022
September 1, 2022
2 months
March 3, 2022
September 8, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Change in appetite
Parents will complete a study specific survey which will include questions about child's interest in food and food intake which will yield an appetite score.
Baseline to 14 days
Change in gastrointestinal health
Parents will complete a study specific survey which will include questions about child's gastrointestinal symptoms such as diarrhea, vomiting, nausea, bloating, or constipation to yield a gastrointestinal health score.
Baseline to 14 days
Change in 2 hour Lactulose mannitol ratio
Assessment of Lactulose mannitol ratio at baseline and day 14
Baseline to 14 days
Secondary Outcomes (5)
Residual intervention volume
14 days
Fecal lactoferrin
14 days
Fecal myeloperoxidase
14 days
Fecal neopterin
14 days
Fecal Reg 1 beta
14 days
Study Arms (2)
Enterade (VS001)
EXPERIMENTAL237 mL (8 fluid oz) per os, once daily for 14 days
Placebo
PLACEBO COMPARATOR237 mL (8 fluid oz) per os, once daily for 14 days
Interventions
Enterade is a glucose-free, amino acid-based medical food containing specific amino acids (aspartic acid, valine, serine, threonine and tyrosine) in addition to electrolytes and a non-sugar sweetener.
The placebo is an identical product to Enterade except without added amino acids.
Eligibility Criteria
You may qualify if:
- Length-for-age Z score (LAZ) between -1 and -3 standard deviations
- Lactulose mannitol ratio \>0.09
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey R Donowitz, MD
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2022
First Posted
March 22, 2022
Study Start
July 18, 2022
Primary Completion
September 7, 2022
Study Completion
September 7, 2022
Last Updated
September 10, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share