Status:
COMPLETED
Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea
Lead Sponsor:
PanTheryx, Inc.
Conditions:
Acute Diarrhea
Eligibility:
All Genders
6-5 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01814202
Start Date
March 1 2013
End Date
September 1 2013
Last Update
October 7 2013
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Dhaka Division, Bangladesh, 1212