Low-grade Oral DysplasiaPhase 3NCT05707702
Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
A Phase 3 study testing Probiotic oral lozenges in people with Low-grade Oral Dysplasia, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low-grade Oral Dysplasia
- What is being tested?
- Probiotic oral lozenges
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of biopsy-proven low-grade or mild oral dysplasia
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low-grade Oral Dysplasia
- Being tested
- Probiotic oral lozenges, Standard of care for oral dysplasia
- Keywords
- Probiotic lozenge, Oral cavity squamous cell carcinoma, Oral microbiome
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic oral lozengesBiological
Also called FLORASSIST® Oral Hygiene 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.
Standard of care for oral dysplasiaOther
Oral dysplasia standard of care includes clinical surveillance and risk factor reduction (such as smoking cessation).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic lozenges | Experimental | 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. Receives: Biological: Probiotic oral lozenges |
| Standard of care for oral dysplasia | Active comparator | Participants in this arm will receive oral dysplasia standard of care. Receives: Other: Standard of care for oral dysplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical regression of dysplastic lesion
This outcome will be assessed using blinded review of clinical photographs and measurements of the lesions to determine if the lesion has regressed, remained the same or progressed since baseline.
Measured: 6 weeks
Secondary outcomes (3)
Microbiome at the lesion site
The microbiome at the lesion site will be compared with the contralateral normal tissue to determine whether the dysbiotic oral microbiome will show a reduction in the abundance of oral cancer-associated microbial populations after treatment with the probiotic lozenge, and whether any changes seen will persist after cessation of treatment. The analysis of the microbiology specimens will include 16s sequencing and analysis.
Measured: baseline, 6 weeks, 12 weeks
Change in peri-tumoral inflammation
Peri-tumoral inflammation will be assessed by analyzing populations of tumor-associated macrophages and tumor-infiltrating lymphocytes in the biopsy performed after 6 weeks of treatment compared to the pre-treatment biopsy.
Measured: baseline, 6 weeks
Oral dysplasia lesions at 12 weeks
This outcome will be assessed using blinded review of clinical photographs and measurements of the lesions to determine if the lesion has regressed, remained the same or progressed.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start29 Apr 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: The study did not start as a key co-investigator left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-grade Oral DysplasiaStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Heather Edwards, MD, Principal investigator, Boston Medical Center, Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707702
- Sponsor's protocol ID
- H-42906
- Status last verified
- Apr 2024
- First submitted
- 10 Dec 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
- ClinicalTrials.gov ID
- NCT05707702
- Acronym / sponsor ID
- H-42906
- Conditions
- Low-grade Oral Dysplasia
- Keywords
- Probiotic lozenge, Oral cavity squamous cell carcinoma, Oral microbiome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not start as a key co-investigator left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 29 Apr 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic lozenges | Experimental | Biological: Probiotic oral lozengesParticipants 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 | Active comparator | Other: Standard of care for oral dysplasiaParticipants in this arm will receive oral dysplasia standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of biopsy-proven low-grade or mild oral dysplasia
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic oral lozengesAlso: FLORASSIST® Oral Hygiene lozengesParticipants 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 lozenges |
| Standard of care for oral dysplasiaOral dysplasia standard of care includes clinical surveillance and risk factor reduction (such as smoking cessation). | Other | Standard of care for oral dysplasia |
Primary outcome
Clinical regression of dysplastic lesion
Time frame: 6 weeks
This outcome will be assessed using blinded review of clinical photographs and measurements of the lesions to determine if the lesion has regressed, remained the same or progressed since baseline.
3 secondary outcomes
Microbiome at the lesion site
Time frame: baseline, 6 weeks, 12 weeks
Change in peri-tumoral inflammation
Time frame: baseline, 6 weeks
Oral dysplasia lesions at 12 weeks
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Edwards, MD principal investigator
Boston Medical Center, Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic oral lozenges in people with Low-grade Oral Dysplasia, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical regression of dysplastic lesion (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.