PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

University of Virginia

Status: Completed

Conditions: Environmental Enteric Dysfunction

Treatments: Dietary Supplement: micro-nutrient sprinkles; Dietary Supplement: PTM202

Study type: Interventional

Funder types: Other

Identifiers

NCT03263871

19993

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 6 to 9 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Intervention

Experimental group

Description:

PTM202 and micro-nutrient sprinkles

Treatment:

Dietary Supplement: micro-nutrient sprinkles

Dietary Supplement: PTM202

Control

Other group

Description:

micro-nutrient sprinkles

Treatment:

Dietary Supplement: micro-nutrient sprinkles