Head and Neck Malignant TumorsPhase 2NCT06285591
Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors
A Phase 2 study testing Lactobacillus reuteri Tablets and Radiotherapy in people with Head and Neck Malignant Tumors, run by West China Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Lactobacillus reuteri for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Malignant Tumors
- What is being tested?
- Lactobacillus reuteri Tablets and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Jan 2025
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Aged 18-80 years;
- Eastern Cooperative Oncology Group performance status of ≤2;
- Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
- Sign informed consent.
Who cannot join
- Patients with known allergy to probiotic or severe allergic constitution;
- Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- Poor oral hygiene and/or severe periodontal diseases;
- History of head and neck radiotherapy;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
To evaluate the efficacy and safety of Lactobacillus reuteri for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
Read the detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of Lactobacillus reuteri in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Lactobacillus reuteri can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy.
Participants will be instructed to suck a Lactobacillus reuteri or placebo lozenge twice daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.
Researchers will compare Lactobacillus reuteri group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.
- Conditions
- Head and Neck Malignant Tumors
- Being tested
- Lactobacillus reuteri Tablets, Placebo-containing tablets, Radiotherapy
- Keywords
- Head and Neck Malignant Tumors, Radiation-induced oral mucositis, Lactobacillus reuteri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri TabletsDrug
Lactobacillus reuteri lozenges (NOW Foods, Sweden) contained 2×10^8 CFU viable cells of Lactobacillus reuteri as the active ingredient.
Placebo-containing tabletsDrug
The placebo lozenges shared the same formulation as the L. reuteri lozenges but without the probiotic, whose appearance, taste, and color were identical to those of the Lactobacillus reuteri lozenges.
RadiotherapyRadiation
One of the inclusion criteria for the study was that patients with malignant tumors of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Placebo-containing tablets Receives: Drug: Placebo-containing tablets; Radiation: Radiotherapy |
| Experimental group | Experimental | Lactobacillus reuteri tablets Receives: Drug: Lactobacillus reuteri Tablets; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of severe oral mucositis (SOM) (WHO grade ≥3)
Oral mucositis is assessed by trained radiotherapists according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Secondary outcomes (5)
The time to onset of severe oral mucositis (SOM) (WHO grade ≥3)
Time from the first day of radiotherapy to the first determination of SOM.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The duration of severe oral mucositis (WHO grade ≥3)
The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The incidence of oral mucositis (OM)
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The time to onset of any-grade oral mucositis (OM)
Time from the first day of radiotherapy to the first determination of OM.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The duration of any-grade oral mucositis (OM)
The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Malignant TumorsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285591
- Sponsor's protocol ID
- 2023-1801
- Status last verified
- Dec 2025
- First submitted
- 6 Feb 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06285591
- Acronym / sponsor ID
- 2023-1801
- Conditions
- Head and Neck Malignant Tumors
- Keywords
- Head and Neck Malignant Tumors, Radiation-induced oral mucositis, Lactobacillus reuteri
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 29 Feb 2024 (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.
To evaluate the efficacy and safety of Lactobacillus reuteri for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
Detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of Lactobacillus reuteri in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Lactobacillus reuteri can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy.
Participants will be instructed to suck a Lactobacillus reuteri or placebo lozenge twice daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.
Researchers will compare Lactobacillus reuteri group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placebo-containing tablets, Radiation: RadiotherapyPlacebo-containing tablets |
| Experimental group | Experimental | Drug: Lactobacillus reuteri Tablets, Radiation: RadiotherapyLactobacillus reuteri tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Aged 18-80 years;
- Eastern Cooperative Oncology Group performance status of ≤2;
- Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
- Sign informed consent.
Key exclusion criteria (5 listed)
- Patients with known allergy to probiotic or severe allergic constitution;
- Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- Poor oral hygiene and/or severe periodontal diseases;
- History of head and neck radiotherapy;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
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 |
|---|---|---|
| Lactobacillus reuteri TabletsLactobacillus reuteri lozenges (NOW Foods, Sweden) contained 2×10^8 CFU viable cells of Lactobacillus reuteri as the active ingredient. | Drug | Experimental group |
| Placebo-containing tabletsThe placebo lozenges shared the same formulation as the L. reuteri lozenges but without the probiotic, whose appearance, taste, and color were identical to those of the Lactobacillus reuteri lozenges. | Drug | Control group |
| RadiotherapyOne of the inclusion criteria for the study was that patients with malignant tumors of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy. | Radiation | Control group, Experimental group |
Primary outcome
The incidence of severe oral mucositis (SOM) (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Oral mucositis is assessed by trained radiotherapists according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat.
5 secondary outcomes
The time to onset of severe oral mucositis (SOM) (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The duration of severe oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The incidence of oral mucositis (OM)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The time to onset of any-grade oral mucositis (OM)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The duration of any-grade oral mucositis (OM)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- 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.
Xingchen Peng principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus reuteri Tablets and Radiotherapy in people with Head and Neck Malignant Tumors, run by West China Hospital at 1 site in China.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Dec 2025. 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 China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of severe oral mucositis (SOM) (WHO grade ≥3) (time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 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 19 Dec 2025.