Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT01192802
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2010-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D006725', 'term': 'Hookworm Infections'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017206', 'term': 'Strongylida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015766', 'term': 'Albendazole'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-23', 'studyFirstSubmitDate': '2010-08-31', 'studyFirstSubmitQcDate': '2010-08-31', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'parasite cleared and reduced up to 80% at day 42', 'timeFrame': '42 days'}], 'secondaryOutcomes': [{'measure': 'Prevalence of major gut bacteria', 'timeFrame': '42 days', 'description': 'Change in the prevalence of major gut bacteria after antihelminth treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['albendazole', 'ascaris', 'trichiurus', 'hookworms'], 'conditions': ['Intestinal Diseases', 'Helminthiasis']}, 'referencesModule': {'references': [{'pmid': '24550339', 'type': 'DERIVED', 'citation': 'Adegnika AA, Zinsou JF, Issifou S, Ateba-Ngoa U, Kassa RF, Feugap EN, Honkpehedji YJ, Dejon Agobe JC, Kenguele HM, Massinga-Loembe M, Agnandji ST, Mordmuller B, Ramharter M, Yazdanbakhsh M, Kremsner PG, Lell B. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection. Antimicrob Agents Chemother. 2014 May;58(5):2535-40. doi: 10.1128/AAC.01317-13. Epub 2014 Feb 18.'}], 'seeAlsoLinks': [{'url': 'http://www.lambarene.org', 'label': 'Medical Research Unit of the Albert Schweitzer Hospital'}]}, 'descriptionModule': {'briefSummary': 'Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy in the school children population. The aim of this study is to evaluate the efficacy of the albendazole one versus two and three doses, in school children infected with intestinal helminth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of intestinal helminths eggs in the stool\n\nExclusion Criteria:\n\n* allergy to imidazole derivate\n* No intestinal helminths'}, 'identificationModule': {'nctId': 'NCT01192802', 'briefTitle': 'Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora', 'organization': {'class': 'OTHER', 'fullName': 'Albert Schweitzer Hospital'}, 'officialTitle': 'Effect of Intestinal Helminths on Gut Microflora', 'orgStudyIdInfo': {'id': 'Albendazole-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 dose, Albendazole , tablet', 'interventionNames': ['Drug: albendazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 doses, albendazole, tablet', 'description': '1 tablet of 400 mg of albendazole per day for two consecutive days', 'interventionNames': ['Drug: albendazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 doses albendazole, 400mg, tablet', 'interventionNames': ['Drug: albendazole']}], 'interventions': [{'name': 'albendazole', 'type': 'DRUG', 'description': '1 tablet of 400 mg of albendazole per day for three consecutive days', 'armGroupLabels': ['3 doses albendazole, 400mg, tablet']}, {'name': 'albendazole', 'type': 'DRUG', 'description': 'single 1 tablet of 400 mg of albendazole', 'armGroupLabels': ['1 dose, Albendazole , tablet']}, {'name': 'albendazole', 'type': 'DRUG', 'description': '1 tablet of 400 mg of albendazole per day for two consecutive days', 'armGroupLabels': ['2 doses, albendazole, tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '118', 'city': 'Lambaréné', 'state': 'Moyen-Ogooué Province', 'country': 'Gabon', 'facility': 'Medical research Unit of Lambaréné', 'geoPoint': {'lat': -0.7001, 'lon': 10.24055}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Schweitzer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Ayola Akim ADEGNIKA', 'oldOrganization': 'Medical Research Unit'}}}}