Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-03 @ 9:52 AM
Study NCT ID:
NCT02085694
Status:
UNKNOWN
Last Update Posted:
2014-03-13
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactobacillus Brevis CD2 Preventing Oral Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052016', 'term': 'Mucositis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-08', 'studyFirstSubmitDate': '2014-03-06', 'studyFirstSubmitQcDate': '2014-03-08', 'lastUpdatePostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis', 'timeFrame': 'days -14;-7; 0;+7;+14;+21'}], 'secondaryOutcomes': [{'measure': 'COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM', 'timeFrame': 'days -14;-7; 0; +7;+14; +21'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mucositis']}, 'descriptionModule': {'briefSummary': 'A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT.\n\nClinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Karnofsky Performance Score ≥ 70%.\n* Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy\n* Patients eligible to receive high-dose chemotherapy as part of conditioning regimen\n* Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)\n* Serum creatinine \\< 1.8mg/dl\n* Total bilirubin \\< 2mg/dl\n* Liver enzymes within three times of normal limit\n* Expected survival \\> 6 months.\n\nExclusion Criteria:\n\n* Pregnant women and lactating mothers\n* Patients with history of HIV infection\n* Patients who have taken any other investigational product in last 4 weeks\n* Patients having untreated symptomatic dental infection\n* Patients with WHO Grade 3 or 4 oral Mucositis\n* Other serious concurrent illness\n* Inconclusive hematological diagnosis\n* Patients with signs and symptoms of systemic infections\n* Patient's/guardian's refusal to sign informed consent"}, 'identificationModule': {'nctId': 'NCT02085694', 'briefTitle': 'Lactobacillus Brevis CD2 Preventing Oral Mucositis', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'A Pilot Study on the Efficacy of Lactobacillus Brevis CD2 Lozenges in Preventing Oral Mucositis by High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': '001/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus brevis CD2 lozenges', 'interventionNames': ['Drug: Lactobacillus brevis CD2']}], 'interventions': [{'name': 'Lactobacillus brevis CD2', 'type': 'DRUG', 'armGroupLabels': ['Lactobacillus brevis CD2 lozenges']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Patrizia Chiusolo, MD', 'role': 'CONTACT', 'email': 'p.chiusolo@rm.unicatt.it', 'phone': '0039-0630155300'}, {'name': 'Sabrina Giammarco, MD', 'role': 'CONTACT', 'email': 'sabrina_giammarco@libero.it', 'phone': '0039-0630155300'}, {'name': 'Patrizia Chiusolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sabrina Giammarco, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Policlinico Universitario "A. GEMELLI"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'sabrina giammarco', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}