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Completed

NCT Number: NCT03263871

PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.

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Key information

Conditions

Environmental Enteric Dysfunction

Age range

6 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 6 - 9 months old
  • -1> Weight-for-age Z score > -3
  • Parental consent to participate and receive daily supplementation with either PTM202 and/or micro-nutrient sprinkles, participate in specimen collection

Exclusion criteria

  • Presence of known kidney, liver, heart, developmental, or neurologic disease
  • Allergy to milk and/or egg (assessed by history)
  • Milk intolerance (assessed by history)
  • Abnormal liver or kidney function tests
  • Family is planning to move from the study area or children is enrolled to the other clinical trial within 3 months of follow up
  • Child being exclusively breast fed at the time of enrollment

Treatment and study plan

PTM202

Dietary Supplement

PTM202 given twice daily for 30 days.

micro-nutrient sprinkles

Dietary Supplement

Micro-nutrient sprinkles will be given twice daily for 30 days.

Primary outcomes

  1. EED biomarker composite score

    Time frame: 4 months

    composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein

Secondary outcomes

  1. Weight gain

    Time frame: 4 months

  2. Height gain

    Time frame: 4 months

  3. Number of diarrheal episodes

    Time frame: 4 months

  4. Glucose hydrogen breath test

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Virginia Commonwealth University

Registry information

Official study title

Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 28, 2017
Registry last updated
Apr 22, 2019

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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