WithdrawnPhase 3

Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

Stopped: The study did not start as a key co-investigator left the institution.

United States0Started 2024-04-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical regression of dysplastic lesion

Timeframe: 6 weeks

Trial details

NCT IDNCT05707702

SponsorBoston Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

View on ClinicalTrials.gov More Low-grade Oral Dysplasia trials