Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-02 @ 12:56 AM
Study NCT ID:
NCT00732732
Status:
TERMINATED
Last Update Posted:
2011-08-08
First Post:
2008-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Controlled Trial of Plantain Powder in Infantile Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003968', 'term': 'Diarrhea, Infantile'}, {'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': 'C109691', 'term': 'microcrystalline cellulose'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-05', 'studyFirstSubmitDate': '2008-08-08', 'studyFirstSubmitQcDate': '2008-08-11', 'lastUpdatePostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of stools per day.', 'timeFrame': 'Daily for 10 days'}], 'secondaryOutcomes': [{'measure': 'Change in the consistency of stool.', 'timeFrame': 'Daily for 10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diarrhea', 'Plantain', 'Green banana', 'Infants', 'Children'], 'conditions': ['Diarrhea, Infantile']}, 'referencesModule': {'references': [{'pmid': '15139502', 'type': 'RESULT', 'citation': 'Rabbani GH, Teka T, Saha SK, Zaman B, Majid N, Khatun M, Wahed MA, Fuchs GJ. Green banana and pectin improve small intestinal permeability and reduce fluid loss in Bangladeshi children with persistent diarrhea. Dig Dis Sci. 2004 Mar;49(3):475-84. doi: 10.1023/b:ddas.0000020507.25910.cf.'}, {'pmid': '11522739', 'type': 'RESULT', 'citation': 'Rabbani GH, Teka T, Zaman B, Majid N, Khatun M, Fuchs GJ. Clinical studies in persistent diarrhea: dietary management with green banana or pectin in Bangladeshi children. Gastroenterology. 2001 Sep;121(3):554-60. doi: 10.1053/gast.2001.27178.'}]}, 'descriptionModule': {'briefSummary': 'Green banana has been traditionally used in diarrheal and other diseases. Recent studies have shown that green banana is beneficial in children with diarrhea.\n\nThe purpose of this study is to try green banana in a portable, storable and dosable form in infants with diarrhea.\n\nInfants with diarrhea and meeting the inclusion criteria will receive either green banana powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days. The subjects, parents and researchers conducting the study will not know whether banana powder or placebo is being given to that particular subject (double blind randomized study).\n\nTwo hundred patients will be enrolled in 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '5 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children between the ages of 5 months and 2 years of age admitted in the inpatient pediatric ward of Bhatpara Sub divisional Hospital.\n2. Infants with more than 3 stools/day which is more frequent than the usual bowel habit of the study subject\n3. The consistency of the stool is such that it takes the shape of the container into which it is put in.\n4. Duration of symptoms should be less than 14 days.\n\n \\-\n\nExclusion Criteria:\n\n1. Children with bloody diarrhea\n2. Children with lethargy, fever or other signs of septicemia\n3. Children with shock.\n4. Children unable to take medications orally.\n5. Children with impaired consciousness.\n6. Children whose parents refuse permission to be included in the study.\n7. Children who are not usual residents of the area and will not be available for follow up.\n8. Children with chronic illnesses such as congenital heart disease, renal failure, chronic liver disease, chronic lung disease, inflammatory bowel disease, immune deficiency etc.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT00732732', 'briefTitle': 'A Controlled Trial of Plantain Powder in Infantile Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.', 'orgStudyIdInfo': {'id': 'HAC 08-01-165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Green banana', 'description': 'Subjects receiving green banana powder.', 'interventionNames': ['Dietary Supplement: Green banana powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Microcrystalline cellulose given as placebo', 'interventionNames': ['Other: Microcrystalline cellulose']}], 'interventions': [{'name': 'Green banana powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Green banana in powder form, 10 grams/ day for children below 10 kg, 20 grams for those weighing 10 Kg or more. Protocol Modified on Aug 5th 2009 to give 20 grams irrespective of age.', 'armGroupLabels': ['Green banana']}, {'name': 'Microcrystalline cellulose', 'type': 'OTHER', 'description': 'Microcrystalline cellulose 10 gm/ day for subjects below 10 kg in weight, 20 gms/ day for those weighing 10 Kg or more', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N 24 pgs', 'city': 'Bhātpāra', 'state': 'West Bengal', 'country': 'India', 'facility': 'Bhatpara Subdivisional Hospital', 'geoPoint': {'lat': 22.86643, 'lon': 88.40113}}], 'overallOfficials': [{'name': 'Tapas K Sabui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NRS Medical College, Kolkata.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'NRS Medical College, Kolkata, West Bengal, India', 'class': 'UNKNOWN'}, {'name': 'School of Tropical Medicine, Kolkata, West Bengal, India', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Sudipta Misra MD, Professor of Pediatrics', 'oldOrganization': 'Medical College of Georgia'}}}}