NCT01814202CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PanTheryx, Inc.
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- diarrhea duration
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 5 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
PTM202
Experimental
PTM202 is a medical nutrition product
Intervention: PTM202 (Other)
Placebo
Placebo Comparator
The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
diarrhea duration
Time Frame: 7 days
Secondary Outcomes
- stool frequency(7 days)
- stool consistency(7 days)
- food intake(7 days)
Investigators
Study Sites (2)
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