Boston Medical Center
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.
Low-grade Oral Dysplasia
Probiotic oral lozenges
Standard of care for oral dysplasia
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking: | Single |
Primary Purpose: | Prevention |
Official Title: | Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia |
Actual Study Start Date : | April 2024 |
Estimated Primary Completion Date : | November 2025 |
Estimated Study Completion Date : | November 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Probiotic lozenges 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. |
Biological: Probiotic oral lozenges |
Active Comparator: Standard of care for oral dysplasia Participants in this arm will receive oral dysplasia standard of care. |
Other: Standard of care for oral dysplasia |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Boston Medical Center
Boston, Massachusetts, United States, 02118