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Probiotic

Probiotic Lozenges for Oral Dysplasia

Phase 3
Waitlist Available
Led By Heather Edwards, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if giving a probiotic lozenge to patients with low-grade oral dysplasia can reduce risk of malignant transformation and help prevent oral cancer.

Who is the study for?
This trial is for individuals with low-grade or mild oral dysplasia confirmed by biopsy. It's not open to those with active high-grade oral issues, HIV patients with certain conditions, recent chemotherapy or immunotherapy recipients, steroid users, transplant patients on anti-rejection meds, heart valve abnormality cases, pregnant/nursing women, and some others.
What is being tested?
The study tests if probiotic lozenges can help manage low-grade oral dysplasia by reducing inflammation and disease-causing bacteria compared to standard care. Participants will be randomly assigned to receive either the lozenges or standard treatment.
What are the potential side effects?
While specific side effects are not listed for the probiotic lozenges being tested in this trial, common side effects of probiotics may include digestive discomfort such as gas and bloating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical regression of dysplastic lesion
Secondary study objectives
Change in peri-tumoral inflammation
Microbiome at the lesion site
Oral dysplasia lesions at 12 weeks

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Probiotic lozengesExperimental Treatment1 Intervention
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 II: Standard of care for oral dysplasiaActive Control1 Intervention
Participants in this arm will receive oral dysplasia standard of care.

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
402 Previous Clinical Trials
883,895 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,647 Previous Clinical Trials
2,342,391 Total Patients Enrolled
Heather Edwards, MDPrincipal InvestigatorBoston Medical Center, Otolaryngology

Media Library

Probiotic oral lozenges (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05707702 — Phase 3
Oral Dysplasia Research Study Groups: Standard of care for oral dysplasia, Probiotic lozenges
Oral Dysplasia Clinical Trial 2023: Probiotic oral lozenges Highlights & Side Effects. Trial Name: NCT05707702 — Phase 3
Probiotic oral lozenges (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05707702 — Phase 3
~0 spots leftby Nov 2025
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