NCT05707702

Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low-grade Oral Dysplasia

Interventions

Type	Name	Description
BIOLOGICAL	Probiotic oral 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.
OTHER	Standard of care for oral dysplasia	Oral dysplasia standard of care includes clinical surveillance and risk factor reduction (such as smoking cessation).

Timeline

• Start date: 2024-04-29
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2023-02-01
• Last updated: 2024-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study