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Trial record 1 of 1 for:    Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
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PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263871
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Virginia Commonwealth University
Information provided by (Responsible Party):
University of Virginia

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : October 14, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : February 15, 2019

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.

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Weight gain [ Time Frame: 4 months ]
  2. Height gain [ Time Frame: 4 months ]
  3. Number of diarrheal episodes [ Time Frame: 4 months ]
  4. Glucose hydrogen breath test [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263871


Locations
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Bangladesh
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
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Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT03263871    
Other Study ID Numbers: 19993
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs