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Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01814202
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : October 7, 2013
Sponsor:
Information provided by (Responsible Party):
PanTheryx, Inc.

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

Condition or disease Intervention/treatment Phase
Acute Diarrhea Other: PTM202 Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: PTM202
PTM202 is a medical nutrition product
Other: PTM202
Placebo Comparator: Placebo
The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor
Other: Placebo



Primary Outcome Measures :
  1. diarrhea duration [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. food intake [ Time Frame: 7 days ]
  2. stool frequency [ Time Frame: 7 days ]
  3. stool consistency [ Time Frame: 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814202


Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
PanTheryx, Inc.
Investigators
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Principal Investigator: Shafiqul A Sarker, MD International Centre for Diarrhoeal Disease Research, Bangladesh
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Responsible Party: PanTheryx, Inc.
ClinicalTrials.gov Identifier: NCT01814202    
Other Study ID Numbers: PTM.2012.002
PR-13002 ( Other Identifier: icddr,b )
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive