Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 1:42 AM
Study NCT ID:
NCT01521403
Status:
UNKNOWN
Last Update Posted:
2022-08-23
First Post:
2012-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is it Effective to Treat Patients With Blastocystis Hominis Infection?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-16', 'releaseDate': '2023-06-28'}], 'estimatedResultsFirstSubmitDate': '2023-06-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016776', 'term': 'Blastocystis Infections'}], 'ancestors': [{'id': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000562', 'term': 'Amebiasis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2012-01-25', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of gastro-intestinal symptoms', 'timeFrame': '10-14 days after treatment with Metronidazol', 'description': 'The improvement of the following symptoms will be evaluated:\n\n* Presence of unusually soft or unformed stools in the last 3 days (yes or no)\n* Average number of stools per day in the last 3 days\n* Maximal abdominal pain in the last 3 days on a scale from 0-10\n* Bloating in last 3 days on a scale from 0-10\n* Flatulence in last 3 days on a scale from 0-10'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blastocystis hominis', 'Metronidazole'], 'conditions': ['Blastocystis Hominis Infections']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether in the setting of primary health care it is effective to treat with metronidazole returning travellers with gastrointestinal symptoms and B. hominis in the stool or not.', 'detailedDescription': "Prevalence of B. hominis is between 30-50% in developing countries. Many travellers visit developing countries and are therefore at risk to be infected by this parasite. It's frequent that travellers return from developing countries with gastro-intestinal symptoms and approximately 10% of them have B. hominis as the sole parasite identified in the stools. Some anti-infective drugs, including metronidazole, trimethoprim-sulfamethoxazole and nitazoxanide, have shown to have activity against B. hominis, but there is still controversy about the pathogenic potential of B. hominis and there is no consensus about the indications for treatment.\n\nIt is hypothesised that metronidazole is more effective than placebo in returning travellers with gastrointestinal symptoms and B. hominis as the sole intestinal parasite identified in the stool."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years\n* Gastrointestinal symptoms for more than 10 days\n* B. hominis in any quantity in at least one stool specimen out of 3 examined\n* No other pathogenic micro-organism identified\n\nExclusion Criteria:\n\n* Fever \\> 37.5°\n* bloody diarrhoea\n* weight loss \\> 10% of usual body weight\n* significant decrease of general condition\n* oncological diseases\n* immune deficiencies\n* known chronic intestinal diseases\n* use of anti-protozoan drugs in the last 2 weeks\n* use of anti-coagulant treatment or antabuse\n* pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT01521403', 'briefTitle': 'Is it Effective to Treat Patients With Blastocystis Hominis Infection?', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Is it Effective to Treat Patients With Blastocystis Hominis Infection? A Double-blind Placebo Controlled Randomized Trial', 'orgStudyIdInfo': {'id': 'CVMV-Blastocystis hominis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metronidazole', 'description': 'Metronidazole 3x500 mg per day for 10 days', 'interventionNames': ['Drug: Metronidazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 3x1 tablet per day for 10 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metronidazole', 'type': 'DRUG', 'description': '3x500 mg/day for 10 days', 'armGroupLabels': ['Metronidazole']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3x1 tablet per day for 10 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Serge de Valliere, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc, Consultant, Principal Investigator', 'investigatorFullName': 'Serge de Valliere', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-06-28', 'type': 'RELEASE'}, {'date': '2024-02-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Serge de Valliere, MD, MSc, Consultant, Principal Investigator, University of Lausanne Hospitals'}}}}