NCT03263871

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 14, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

August 24, 2017

Last Update Submit

April 19, 2019

Conditions

Environmental Enteric Dysfunction

Keywords

nutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Weight gain

    4 months

  • Height gain

    4 months

  • Number of diarrheal episodes

    4 months

  • Glucose hydrogen breath test

    4 months

Study Arms (2)

Intervention

EXPERIMENTAL

PTM202 and micro-nutrient sprinkles

Dietary Supplement: PTM202Dietary Supplement: micro-nutrient sprinkles

Control

OTHER

micro-nutrient sprinkles

Dietary Supplement: micro-nutrient sprinkles

Interventions

PTM202DIETARY_SUPPLEMENT

PTM202 given twice daily for 30 days.

Intervention
micro-nutrient sprinklesDIETARY_SUPPLEMENT

Micro-nutrient sprinkles will be given twice daily for 30 days.

ControlIntervention

Eligibility Criteria

Age6 Months - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 6 - 9 months old
  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

October 14, 2017

Primary Completion

December 30, 2018

Study Completion

February 15, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)