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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical regression of dysplastic lesion
Secondary outcome measures
Change in peri-tumoral inflammation
Microbiome at the lesion site
Oral dysplasia lesions at 12 weeks
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
382 Previous Clinical Trials
869,339 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,583 Previous Clinical Trials
2,279,984 Total Patients Enrolled
Heather Edwards, MDPrincipal InvestigatorBoston Medical Center, Otolaryngology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am undergoing a stem cell transplant.I am HIV positive with a low CD4 count or detectable viral load.I have a severe precancerous condition in my mouth.I am currently taking steroids that affect my whole body.I have an active cancer in my mouth.I am currently on chemotherapy or immunotherapy, or was within the last 6 months.I am on anti-rejection medication after a transplant.I use injectable drugs for my autoimmune disease.I have a history of heart valve issues or have had a valve replacement.I do not have severe acute intestinal issues or a history of short bowel syndrome.I have a mild abnormality in my mouth confirmed by a biopsy.I have had radiation therapy to my head or neck.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care for oral dysplasia
- Group 2: Probiotic lozenges
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given their stamp of approval to Probiotic lozenges?
"Our team confidently assigns a score of 3 to probiotic lozenges, due to the presence of prior clinical data that supports their efficacy and safety."
Answered by AI
Are there any openings still available for this clinical examination?
"This medical trial, which was initially published on March 1st 2023, is no longer enrolling patients. The latest update to the study's status occurred at January 22nd 2023. However, there are currently 130 other trials searching for volunteers in a similar capacity."
Answered by AI
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