Acute Diarrhea
Conditions
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
Interventions
OTHERPTM202
OTHERPlacebo
Sponsors
PanTheryx, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diarrhea duration | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| food intake | 7 days |
| stool frequency | 7 days |
| stool consistency | 7 days |
Countries
Bangladesh
Outcome results
None listed