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Completed

NCT Number: NCT05291559

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

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.

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Key information

Conditions

Environmental Enteric Dysfunction

Age range

1 year–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

About this study

Primary Objectives

  • To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age
  • To assess the efficacy of Enterade (VS001) in treatment of environmental enteric dysfunction by comparing improvements in 2-h lactulose mannitol ratio between Enterade (VS001) and a placebo.

Secondary Objectives

  • To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children aged 1 to 2 years.
  • To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of intestinal inflammation between Enterade (VS001) and placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enterade

Dietary Supplement

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.

Other names: VS001

Placebo

Dietary Supplement

The placebo is an identical product to Enterade except without added amino acids.

Primary outcomes

  1. Change in appetite

    Time frame: Baseline to 14 days

    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.

  2. Change in gastrointestinal health

    Time frame: Baseline to 14 days

    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.

  3. Change in 2 hour Lactulose mannitol ratio

    Time frame: Baseline to 14 days

    Assessment of Lactulose mannitol ratio at baseline and day 14

Secondary outcomes

  1. Residual intervention volume

    Time frame: 14 days

    Summation of daily residual volume of unconsumed study product

  2. Fecal lactoferrin

    Time frame: 14 days

    Assessment of fecal lactoferrin concentration at baseline and day 14

  3. Fecal myeloperoxidase

    Time frame: 14 days

    Assessment of fecal myeloperoxidase concentration at baseline and day 14

  4. Fecal neopterin

    Time frame: 14 days

    Assessment of fecal neopterin concentration at baseline and day 14

  5. Fecal Reg 1 beta

    Time frame: 14 days

    Assessment of fecal Reg 1 beta concentration at baseline and day 14

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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