Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
Reason given: The study did not start as a key co-investigator left the institution.
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Phase 3
Where in United States
- Boston Medical CenterBoston, United StatesNo longer taking part
Trial details
- Who runs it
- Boston Medical Center
- Trial code
- NCT05707702
- Record updated
- 1 May 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Presence of biopsy-proven low-grade or mild oral dysplasia.
Exclusion: Currently undergoing chemotherapy or immunotherapy, or have used these agents within the prior 6 months; Current use of systemic or orally absorbed steroids; Patient undergoing stem cell transplantation; Patients taking anti-rejection medication after stem cell or solid organ transplantation; Active oral cavity malignancy; History of external beam radiation therapy to the head and neck area; Patients using injectable immunosuppressive drugs for autoimmune disease; Patients with a heart valve abnormalities or a history of valve replacement or endocarditis; Patients with active severe acute intestinal disease (active bowel leak, acute abdomen, active colitis) or a history of short bowel syndrome; Diagnosis of HIV with decreased CD4 count and/or detectable viral load; Active oral cavity high grade dysplasia; Pregnant or nursing women; Patients who are hospitalized.