Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT01679366
Status:
COMPLETED
Last Update Posted:
2014-10-22
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-21', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-09-02', 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'period of disease', 'timeFrame': '10 days', 'description': 'Patients will be followed daily while hospitalized. After discharge patients will fill a daily dairy for 10 days and record symptoms, signs, drinking, eating, and return to normal life. All dairies will be collected on day 10 of the study.'}], 'secondaryOutcomes': [{'measure': 'analysis', 'timeFrame': '10 days', 'description': 'Follow-up throat culture, CBC, CRP, and ESR on day 4 of the study or at discharge if before. For patients with abnormal laboratory tests on admission, repeat tests are performed before discharge according to the routine of the department. For patients with normal tests on admission, these tests will be part of the study. For patients with Streptococcus pyogenes growth on admission and day 4 of the study, another throat culture will be done on day 10 of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Throat Pain']}, 'descriptionModule': {'briefSummary': 'The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult patients may shorten the duration, and reduce the severity of the disease.', 'detailedDescription': 'Hypothesis The addition of probiotics to the routine therapy of AP in adult patients may shorten the duration, and reduce the severity of the disease.\n\nStudy design A prospective, randomized, placebo-controlled, double-blinded study comparing treatment with probiotics to placebo in patients with AP.\n\nThe study will be conducted in accordance with the ethical standards of the Helsinki Declaration and will be approved by the Human Experimentation Ethics Committee of the Ziv Medical Center. Signed informed consent will be required from all patients before inclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Acute pharyngotonsillitis for which hospitalization for intravenous antibiotic treatment and/or fluids is needed\n\nExclusion Criteria:\n\n* Current therapy with systemic prednisone or equivalent at 20 mg/d for more than 10 days prior to inclusion'}, 'identificationModule': {'nctId': 'NCT01679366', 'briefTitle': 'The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients', 'orgStudyIdInfo': {'id': '0054-11-ZIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Penicillin G', 'description': 'hospitalization of 30 patients given penicilline intraveniously for 72 hours'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '30 hospitalized patients will be given placebo with a regular penicillin treatment', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Probiotics will be given to 30 hospitalized patients with regular penicillin treatment', 'interventionNames': ['Drug: Probiotics']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill for mimic probiotics'], 'description': '1 tablet 2 times daily', 'armGroupLabels': ['Placebo']}, {'name': 'Probiotics', 'type': 'DRUG', 'otherNames': ['BLIS'], 'description': '1 tablet twice daily', 'armGroupLabels': ['Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Safed', 'country': 'Israel', 'facility': 'Ziv Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'overallOfficials': [{'name': 'Leonid Livshits, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziv Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}