Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

Phase 3

Withdrawn

• Conditions: Low-grade Oral Dysplasia
• Interventions: Biological: Probiotic oral lozenges; Other: Standard of care for oral dysplasia

• Registration Number: NCT05707702
• Lead Sponsor: Boston Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-10
• Study First Submitted QC: 2023-01-22
• Study First Posted: 2023-02-01
• Status Verified: 2024-04
• Study Start: 2024-04-29
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic lozenges	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.
Standard of care for oral dysplasia	Standard of care for oral dysplasia	Participants in this arm will receive oral dysplasia standard of care.

Primary Outcome Measures

Name	Time	Method
Clinical regression of dysplastic lesion	6 weeks	This outcome will be assessed using blinded review of clinical photographs and measurements of the lesions to determine if the lesion has regressed, remained the same or progressed since baseline.

Secondary Outcome Measures

Name	Time	Method
Oral dysplasia lesions at 12 weeks	12 weeks	This outcome will be assessed using blinded review of clinical photographs and measurements of the lesions to determine if the lesion has regressed, remained the same or progressed.
Microbiome at the lesion site	baseline, 6 weeks, 12 weeks	The microbiome at the lesion site will be compared with the contralateral normal tissue to determine whether the dysbiotic oral microbiome will show a reduction in the abundance of oral cancer-associated microbial populations after treatment with the probiotic lozenge, and whether any changes seen will persist after cessation of treatment. The analysis of the microbiology specimens will include 16s sequencing and analysis.
Change in peri-tumoral inflammation	baseline, 6 weeks	Peri-tumoral inflammation will be assessed by analyzing populations of tumor-associated macrophages and tumor-infiltrating lymphocytes in the biopsy performed after 6 weeks of treatment compared to the pre-treatment biopsy.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States