PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

Environmental Enteric Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263871
• Other study ID #: 19993
• Status: Completed
• Phase: N/A
• Start date: October 14, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: April 2019
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 15, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Environmental Enteric Dysfunction

Intervention

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

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	International Centre for Diarrhoeal Disease Research, Bangladesh, Virginia Commonwealth University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight gain		4 months
Secondary	Height gain		4 months
Secondary	Number of diarrheal episodes		4 months
Secondary	Glucose hydrogen breath test		4 months