PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

Overview

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

Full Title of Study: “Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 30, 2018

Interventions

  • Dietary Supplement: PTM202
    • PTM202 given twice daily for 30 days.
  • Dietary Supplement: micro-nutrient sprinkles
    • Micro-nutrient sprinkles will be given twice daily for 30 days.

Arms, Groups and Cohorts

  • Experimental: Intervention
    • PTM202 and micro-nutrient sprinkles
  • Other: Control
    • micro-nutrient sprinkles

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Weight gain
    • Time Frame: 4 months
  • Height gain
    • Time Frame: 4 months
  • Number of diarrheal episodes
    • Time Frame: 4 months
  • Glucose hydrogen breath test
    • Time Frame: 4 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 9 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Virginia
  • Collaborator
    • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Provider of Information About this Clinical Study
    • Sponsor

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