PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03263871
• Collaborator: International Centre for Diarrhoeal Disease Research, Bangladesh (Other), Virginia Commonwealth University (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 12.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Environmental Enteric Dysfunction	Dietary Supplement: PTM202; Dietary Supplement: micro-nutrient sprinkles	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
• Actual Study Start Date: Oct 14, 2017
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Feb 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. EED biomarker composite score [4 months]

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

Secondary Outcome Measures

1. Weight gain [4 months]

2. Height gain [4 months]

3. Number of diarrheal episodes [4 months]

4. Glucose hydrogen breath test [4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 9 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka		Bangladesh

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Virginia
• ClinicalTrials.gov Identifier: NCT03263871
• Other Study ID Numbers: 19993
• First Posted: Aug 28, 2017
• Last Update Posted: Apr 22, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Virginia: nutrition
• Additional relevant MeSH terms: Micronutrients; Trace Elements

Study Results

No Results Posted as of Apr 22, 2019