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Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea

NCT ID: NCT01814202

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this study is to determine whether a medical nutrition product, PTM202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children

Detailed Description

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Conditions

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Acute Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PTM202

PTM202 is a medical nutrition product

Group Type EXPERIMENTAL

PTM202

Intervention Type OTHER

Placebo

The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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PTM202

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* males or females between 6 months and 5 years of age
* acute diarrhea (\<48 hours) without interfering co-morbidities
* guardian willing to have child admitted to hospital as an inpatient for 96 hours and to return to the clinic with the child on Day 7 for a final evaluation
* Guardian is willing and able to report to the Investigator information on stool frequency, stool consistency and food and water intakes during the follow up phase.
* Written informed consent must be obtained prior to admission to this study.
* The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.

Exclusion Criteria

* Suspected or confirmed cholera
* Suspected dysentery
* Symptom duration \>48 hours at screening
* Vomiting severity that is like to make administration and retention of test article impossible
* Severe malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6).
* Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening.
* History of hypersensitivity or allergy to milk or egg
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PanTheryx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shafiqul A Sarker, MD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

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International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Dhaka Division, Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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PR-13002

Identifier Type: OTHER

Identifier Source: secondary_id

PTM.2012.002

Identifier Type: -

Identifier Source: org_study_id