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Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

NCT05707702 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-05-01

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Heather Edwards, MD · Boston Medical Center, Otolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05707702 on ClinicalTrials.gov