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NCT05707702 | Not yet recruiting | Low-grade Oral Dysplasia


Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
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.

Condition or disease

Low-grade Oral Dysplasia

Intervention/treatment

Probiotic oral lozenges

Standard of care for oral dysplasia

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking: Single
Primary Purpose: Prevention
Official Title: Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
Actual Study Start Date : April 2024
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025
Arm Intervention/treatment

Experimental: 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.

Biological: Probiotic oral lozenges

Active Comparator: Standard of care for oral dysplasia

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

Other: Standard of care for oral dysplasia

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

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Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

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Locations


Not yet recruiting

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

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