Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea

A Double-blind, Randomized, Placebo-controlled Clinical Trial (Pilot Phase) to Evaluate the Efficacy of a Medical Nutrition Product, PTM202, in Children With Acute Diarrhea

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

Study Overview

• Status: Completed
• Conditions: Acute Diarrhea
• Intervention / Treatment: Other: Placebo; Other: PTM202

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1212
    • International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTM202; PTM202 is a medical nutrition product	Other: PTM202
Placebo Comparator: Placebo; The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
diarrhea duration	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
food intake	7 days
stool frequency	7 days
stool consistency	7 days

Collaborators and Investigators

• Sponsor: PanTheryx, Inc.
• Investigators: Principal Investigator: Shafiqul A Sarker, MD, International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: March 18, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Estimate): October 7, 2013
• Last Update Submitted That Met QC Criteria: October 4, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: PTM.2012.002; PR-13002 (Other Identifier: icddr,b)