Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea

Acute Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814202
• Other study ID #: PTM.2012.002
• Secondary ID: PR-13002
• Status: Completed
• Phase: N/A
• First received: March 15, 2013
• Last updated: October 4, 2013
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: PanTheryx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Diarrhea
• Diarrhea

Intervention

Other:
• PTM202

• Placebo

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
PanTheryx, Inc.

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diarrhea duration		7 days	No
Secondary	food intake		7 days	No
Secondary	stool frequency		7 days	No
Secondary	stool consistency		7 days	No