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NCT05707702
Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
Conditions: Low-grade Oral Dysplasia
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 60
Sponsor: Boston Medical Center
Location: United States
Summary
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.The 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.
Eligibility Criteria
Inclusion Criteria:Presence of biopsy-proven low-grade or mild oral dysplasiaExclusion Criteria:Active oral cavity malignancyActive oral cavity high grade dysplasiaCurrently undergoing chemotherapy or immunotherapy, or have used these agents within the prior 6 monthsHistory of external beam radiation therapy to the head and neck areaDiagnosis of HIV with decreased CD4 count and/or detectable viral loadCurrent use of systemic or orally absorbed steroidsPatient undergoing stem cell transplantationPatients taking anti-rejection medication after stem cell or solid organ transplantationPatients using injectable immunosuppressive drugs for autoimmune diseasePregnant or nursing womenPatients who are hospitalizedPatients with a heart valve abnormalities or a history of valve replacement or endocarditisPatients with active severe acute intestinal disease (active bowel leak, acute abdomen, active colitis) or a history of short bowel syndrome
Source: ClinicalTrials.gov (NCT05707702). StuddyBuddy aggregates publicly available trial information.