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Probiotic lozenge tested to shield teeth and jaw from radiation damage

NCT ID NCT07883005

Prevention Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether long-term use of a probiotic lozenge can reduce serious dental problems in people receiving radiation for head and neck cancer. Participants are randomly assigned to receive standard care alone or standard care plus lozenges containing Streptococcus salivarius strain SALI-10. Researchers will track tooth failure and jawbone damage, and also examine changes in the mouth's microbiome and inflammation. The goal is to see whether the probiotic helps prevent these radiation-related complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a probiotic lozenge containing Streptococcus salivarius strain SALI-10
What this could lead to
If it works, this could offer a simple, long-term probiotic lozenge to help protect teeth and jawbone from radiation damage in people treated for head and neck cancer.
What could go wrong
The trial may find that the probiotic does not prevent dental complications, or that benefits do not hold across different patients. Long-term daily use could also prove inconvenient or cause minor oral side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed malignancy of head and neck cancer patient * Patients are planned to receive definitive or postoperative RT (≥45Gy) with or without concurrent systemic therapy. * Participants must have at least one non-hopeless tooth ("hopeless" defined as non-restorable/non-salvageable and indicated for extraction) remaining or expected to remain in the mouth after completing any required pre-RT dental extractions. * Stage T1-4 N0-3 M0 (UICC/AJCC TNM 8th Edition). * Must be ≥ 18 years of age. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Able to provide informed consent Exclusion Criteria: * Patients with history of allergy to probiotics (e.g. itchy skin, diarrhea, rhinitis). * Patients with severe immunocompromise or chronic gastrointestinal conditions that interfere with the use of probiotics * Patients who deem unable to be compliant with probiotic intake (e.g., substance abuse disorders). * Patients who are on antibiotics are not eligible except if the last dose of antibiotics was given 2 weeks prior to study registration. * Patients with head and neck cancers when target volume is far away from the jaw/teeth, such as laryngeal T1-2 N0M0 cancer planned for definitive RT with limited target volume. * Previous head and neck cancer or multiple synchronous primary head and neck cancers. * Previous RT to the head and neck region that would result in significant overlap of RT volume for the current study. * Individuals with severe, active co-morbidity including any of the following: Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization, within 30 days of study registration, Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of study registration, Acute myocardial infarction within 30 days of study registration, Diseases precluding RT (e.g., active scleroderma, lupus or inflammatory bowel disease) \- Women who are pregnant or plan on becoming pregnant.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms osteoradionecrosis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

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