Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea

PanTheryx

Status

Completed

Conditions

Acute Diarrhea

Treatments

Other: PTM202

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01814202

PTM.2012.002

PR-13002 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

68 patients

Sex

All

Ages

6 months to 5 years old

Volunteers

No Healthy Volunteers

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