Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea

Not Applicable

Completed

• Conditions: Acute Diarrhea
• Interventions: Other: PTM202; Other: Placebo

• Registration Number: NCT01814202
• Lead Sponsor: PanTheryx, Inc.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-19
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-04
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTM202	PTM202	PTM202 is a medical nutrition product
Placebo	Placebo	The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor

Primary Outcome Measures

Name	Time	Method
diarrhea duration	7 days

Secondary Outcome Measures

Name	Time	Method
stool frequency	7 days
stool consistency	7 days
food intake	7 days

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b); 🇧🇩 Dhaka, Bangladesh