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Completed

NCT Number: NCT01814202

Study With Medical Nutrition Product PTM202 in Pediatric 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

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Key information

Conditions

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Dhaka Division, 1212, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTM202

Other

Placebo

Other

Primary outcomes

  1. diarrhea duration

    Time frame: 7 days

Secondary outcomes

  1. food intake

    Time frame: 7 days

  2. stool frequency

    Time frame: 7 days

  3. stool consistency

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

PanTheryx, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Oct 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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