Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-20 @ 12:22 PM
Study NCT ID:
NCT02280759
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2014-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586501', 'term': 'tannate gelatin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of diarrhea', 'timeFrame': '7 days', 'description': 'time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours'}], 'secondaryOutcomes': [{'measure': 'Need of intravenous rehydration due to diarrhea', 'timeFrame': '7 days'}, {'measure': 'Need of hospitalization in outpatients', 'timeFrame': '7 days'}, {'measure': 'Vomiting', 'timeFrame': 'How many times for 7days'}, {'measure': 'Weight gain', 'timeFrame': '7 days'}, {'measure': 'Diarrhea recurrence', 'timeFrame': '7 days'}, {'measure': 'Frequency of watery stools', 'timeFrame': '7 days'}, {'measure': 'Adverse effects', 'timeFrame': '7 days'}, {'measure': 'Severity of diarrhea due to modified Vesikari score', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diarrhea, gelatin tannate, acute gastroenteritis'], 'conditions': ['Acute Gastroenteritis']}, 'referencesModule': {'references': [{'pmid': '29794092', 'type': 'DERIVED', 'citation': 'Kolodziej M, Bebenek D, Konarska Z, Szajewska H. Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial. BMJ Open. 2018 May 24;8(5):e020205. doi: 10.1136/bmjopen-2017-020205.'}, {'pmid': '26895988', 'type': 'DERIVED', 'citation': 'Michalek D, Kolodziej M, Konarska Z, Szajewska H. Efficacy and safety of gelatine tannate for the treatment of acute gastroenteritis in children: protocol of a randomised controlled trial. BMJ Open. 2016 Feb 19;6(2):e010530. doi: 10.1136/bmjopen-2015-010530.'}]}, 'descriptionModule': {'briefSummary': 'Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children \\< 5 years old\n* diarrhea (defined as the passage of 3 or more loose or watery stools per day) for \\> 1 day but \\< 5 days\n* inform consent sign\n\nExclusion Criteria:\n\n* regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission\n* underlying gastrointestinal tract disorder presenting with diarrhea\n* breastfeeding \\>50%\n* malnutrition (weight/high \\<3pc)'}, 'identificationModule': {'nctId': 'NCT02280759', 'briefTitle': 'Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .', 'orgStudyIdInfo': {'id': 'KB56/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gelatin Tannate', 'description': 'Gelatin Tannate:\n\n4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years.', 'interventionNames': ['Drug: Gelatin Tannate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo consists of an identical formulation, except active substance.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gelatin Tannate', 'type': 'DRUG', 'armGroupLabels': ['Gelatin Tannate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo consists of an identical formulation, except active substance', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-183', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Paediatrics, The Medical University of Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Hanna Szajewska, Profesor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}