PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

Pilot Study of 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.

Study Overview

• Status: Completed
• Conditions: Environmental Enteric Dysfunction
• Intervention / Treatment: Dietary supplement: PTM202; Dietary supplement: micro-nutrient sprinkles

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; PTM202 and micro-nutrient sprinkles	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.
Other: Control; micro-nutrient sprinkles	Dietary supplement: micro-nutrient sprinkles; Micro-nutrient sprinkles will be given twice daily for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EED biomarker composite score	composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight gain	4 months
Height gain	4 months
Number of diarrheal episodes	4 months
Glucose hydrogen breath test	4 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2017
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: nutrition
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 19993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No