Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-01 @ 11:41 PM
Study NCT ID:
NCT01814202
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2013-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-04', 'studyFirstSubmitDate': '2013-03-15', 'studyFirstSubmitQcDate': '2013-03-18', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diarrhea duration', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'food intake', 'timeFrame': '7 days'}, {'measure': 'stool frequency', 'timeFrame': '7 days'}, {'measure': 'stool consistency', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Diarrhea']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males or females between 6 months and 5 years of age\n* acute diarrhea (\\<48 hours) without interfering co-morbidities\n* 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\n* 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.\n* Written informed consent must be obtained prior to admission to this study.\n* The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.\n\nExclusion Criteria:\n\n* Suspected or confirmed cholera\n* Suspected dysentery\n* Symptom duration \\>48 hours at screening\n* Vomiting severity that is like to make administration and retention of test article impossible\n* Severe malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6).\n* Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening.\n* History of hypersensitivity or allergy to milk or egg'}, 'identificationModule': {'nctId': 'NCT01814202', 'briefTitle': 'Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'PanTheryx, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PTM.2012.002'}, 'secondaryIdInfos': [{'id': 'PR-13002', 'type': 'OTHER', 'domain': 'icddr,b'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTM202', 'description': 'PTM202 is a medical nutrition product', 'interventionNames': ['Other: PTM202']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'PTM202', 'type': 'OTHER', 'armGroupLabels': ['PTM202']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1212', 'city': 'Dhaka', 'state': 'Dhaka Division', 'country': 'Bangladesh', 'facility': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Shafiqul A Sarker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PanTheryx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}