Back to resultsStudy With Medical Nutrition Product PTM202 in Pediatric Diarrhea
Primary Purpose
Acute Diarrhea
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
PTM202
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Diarrhea
Eligibility Criteria
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
Sites / Locations
- International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PTM202
Placebo
Arm Description
PTM202 is a medical nutrition product
The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor
Outcomes
Primary Outcome Measures
diarrhea duration
Secondary Outcome Measures
food intake
stool frequency
stool consistency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01814202
Brief Title
Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PanTheryx, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTM202
Arm Type
Experimental
Arm Description
PTM202 is a medical nutrition product
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor
Intervention Type
Other
Intervention Name(s)
PTM202
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
diarrhea duration
Time Frame
7 days
Secondary Outcome Measure Information:
Title
food intake
Time Frame
7 days
Title
stool frequency
Time Frame
7 days
Title
stool consistency
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shafiqul A Sarker, MD
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
12. IPD Sharing Statement
Learn more about this trial
Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea
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