Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotic Use in Patients With Prior COPD Exacerbation

NCT02185092

COPD Obstructive Lung Disease

WITHDRAWN NA

Prevention of Asthma and Allergy by Probiotic Lactobacillus GG

NCT00490425

Allergic Asthma

COMPLETED PHASE4

Lactobacillus Brevis CD2 Preventing Oral Mucositis

NCT02085694

Mucositis

UNKNOWN PHASE2/PHASE3

Probiotics in Radiation-treated Gynecologic Cancer

NCT02351089

Gastrointestinal Toxicity Gynecologic Cancer

TERMINATED NA

Lactobacillus GG Supplementation During Pediatric Burn Injuries

NCT00220519

Burns

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low-grade Oral Dysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Probiotic oral lozenges

Intervention Type BIOLOGICAL

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

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

Group Type ACTIVE_COMPARATOR

Standard of care for oral dysplasia

Intervention Type OTHER

Oral dysplasia standard of care includes clinical surveillance and risk factor reduction (such as smoking cessation).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Standard of care for oral dysplasia

Oral dysplasia standard of care includes clinical surveillance and risk factor reduction (such as smoking cessation).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FLORASSIST® Oral Hygiene lozenges

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No