Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

Boston Medical Center (BMC)

Status and phase: Withdrawn; Phase 3

Conditions: Low-grade Oral Dysplasia

Treatments: Biological: Probiotic oral lozenges; Other: Standard of care for oral dysplasia

Study type: Interventional

Funder types: Other

Identifiers

NCT05707702

H-42906

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of biopsy-proven low-grade or mild oral dysplasia

Exclusion criteria

• Active oral cavity malignancy
• Active oral cavity high grade dysplasia
• Currently undergoing chemotherapy or immunotherapy, or have used these agents within the prior 6 months
• History of external beam radiation therapy to the head and neck area
• Diagnosis of HIV with decreased CD4 count and/or detectable viral load
• 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
• Patients using injectable immunosuppressive drugs for autoimmune disease
• Pregnant or nursing women
• Patients who are hospitalized
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Probiotic lozenges

Experimental group

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.

Treatment:

Biological: Probiotic oral lozenges

Standard of care for oral dysplasia

Active Comparator group

Description:

Participants in this arm will receive oral dysplasia standard of care.

Treatment:

Other: Standard of care for oral dysplasia