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

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

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