Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05707702
Status:
WITHDRAWN
Last Update Posted:
2024-05-01
First Post:
2022-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study did not start as a key co-investigator left the institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-04-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2022-12-10', 'studyFirstSubmitQcDate': '2023-01-22', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical regression of dysplastic lesion', 'timeFrame': '6 weeks', 'description': 'This outcome will be assessed using blinded review of clinical photographs and measurements of the lesions to determine if the lesion has regressed, remained the same or progressed since baseline.'}], 'secondaryOutcomes': [{'measure': 'Microbiome at the lesion site', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'The microbiome at the lesion site will be compared with the contralateral normal tissue to determine whether the dysbiotic oral microbiome will show a reduction in the abundance of oral cancer-associated microbial populations after treatment with the probiotic lozenge, and whether any changes seen will persist after cessation of treatment. The analysis of the microbiology specimens will include 16s sequencing and analysis.'}, {'measure': 'Change in peri-tumoral inflammation', 'timeFrame': 'baseline, 6 weeks', 'description': 'Peri-tumoral inflammation will be assessed by analyzing populations of tumor-associated macrophages and tumor-infiltrating lymphocytes in the biopsy performed after 6 weeks of treatment compared to the pre-treatment biopsy.'}, {'measure': 'Oral dysplasia lesions at 12 weeks', 'timeFrame': '12 weeks', 'description': 'This outcome will be assessed using blinded review of clinical photographs and measurements of the lesions to determine if the lesion has regressed, remained the same or progressed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotic lozenge', 'Oral cavity squamous cell carcinoma', 'Oral microbiome'], 'conditions': ['Low-grade Oral Dysplasia']}, 'descriptionModule': {'briefSummary': 'There are limited evidence-based management options for patients with low-grade oral dysplasia. Despite the risk of malignant transformation, management is frequently limited to risk factor reduction (such as smoking cessation) and clinical surveillance. An intervention for low-grade oral dysplasia which could induce regression or decrease rates of malignant transformation has the potential to be a valuable preventative tool to reduce rates of oral cancer.\n\nThe investigators will conduct a randomized clinical trial to investigate if the administration of a probiotic lozenge to patients with low-grade oral dysplasia result in decreased peri-tumoral inflammation as evidenced by impacts on populations of tumor-associated macrophages and tumor-infiltrating lymphocytes, and decreased dysbiosis at the disease site compared with the contralateral normal site. The investigators hypothesize that these changes may increase the rate of clinical regression of these lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of biopsy-proven low-grade or mild oral dysplasia\n\nExclusion Criteria:\n\n* Active oral cavity malignancy\n* Active oral cavity high grade dysplasia\n* Currently undergoing chemotherapy or immunotherapy, or have used these agents within the prior 6 months\n* History of external beam radiation therapy to the head and neck area\n* Diagnosis of HIV with decreased CD4 count and/or detectable viral load\n* Current use of systemic or orally absorbed steroids\n* Patient undergoing stem cell transplantation\n* Patients taking anti-rejection medication after stem cell or solid organ transplantation\n* Patients using injectable immunosuppressive drugs for autoimmune disease\n* Pregnant or nursing women\n* Patients who are hospitalized\n* Patients with a heart valve abnormalities or a history of valve replacement or endocarditis\n* Patients with active severe acute intestinal disease (active bowel leak, acute abdomen, active colitis) or a history of short bowel syndrome'}, 'identificationModule': {'nctId': 'NCT05707702', 'briefTitle': 'Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia', 'orgStudyIdInfo': {'id': 'H-42906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic lozenges', 'description': 'Participants in this arm will be be instructed to take a lozenge daily for 6 weeks. They will also receive oral dysplasia standard of care.', 'interventionNames': ['Biological: Probiotic oral lozenges']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care for oral dysplasia', 'description': 'Participants in this arm will receive oral dysplasia standard of care.', 'interventionNames': ['Other: Standard of care for oral dysplasia']}], 'interventions': [{'name': 'Probiotic oral lozenges', 'type': 'BIOLOGICAL', 'otherNames': ['FLORASSIST® Oral Hygiene lozenges'], 'description': 'Participants in this arm will be be instructed to take a lozenge daily for 6 weeks. They will also receive oral dysplasia standard of care.', 'armGroupLabels': ['Probiotic lozenges']}, {'name': 'Standard of care for oral dysplasia', 'type': 'OTHER', 'description': 'Oral dysplasia standard of care includes clinical surveillance and risk factor reduction (such as smoking cessation).', 'armGroupLabels': ['Standard of care for oral dysplasia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Heather Edwards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center, Otolaryngology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}