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
2 other identifiers
interventional
68
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedOctober 7, 2013
October 1, 2013
6 months
March 15, 2013
October 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
diarrhea duration
7 days
Secondary Outcomes (3)
food intake
7 days
stool frequency
7 days
stool consistency
7 days
Study Arms (2)
PTM202
EXPERIMENTALPTM202 is a medical nutrition product
Placebo
PLACEBO COMPARATORThe placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PanTheryx, Inc.lead
Study Sites (1)
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Dhaka Division, 1212, Bangladesh
Study Officials
- PRINCIPAL INVESTIGATOR
Shafiqul A Sarker, MD
International Centre for Diarrhoeal Disease Research, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2013
First Posted
March 19, 2013
Study Start
March 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
October 7, 2013
Record last verified: 2013-10