Oral MucositisPhase 2NCT06390176
Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy
A Phase 2 study testing Lactobacillus rhamnosus GG and Radiotherapy in people with Oral Mucositis, run by West China Hospital at 1 site in China.
Trial summary
Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Lactobacillus rhamnosus GG 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
- 10 Nov 2023to 31 Mar 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
- Healthy volunteers accepted
- 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;
- Planning to receive definitive RT or postoperative adjuvant RT;
- Normal liver, kidney and bone marrow function;
- Sign informed consent.
Who cannot join
- Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
- Those with poor compliance;
- Pregnancy or breastfeeding;
- History of head and neck radiotherapy;
- Taking antifungal or viral medications one week prior to the start of radiation therapy.
- Other patients (with any other serious other medical condition) who, in the opinion of the investigator, are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients.
Lactobacillus rhamnosus GG (LGG) is a type of lactic acid bacterium, which is an important component of the microbiota in many parts of the human body.
Lactobacillus rhamnosus GG (LGG) is a lactic acid bacterium found in the human body, extensively researched for its probiotic properties. It has been tested in clinical trials for preventing and treating oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma. LGG adheres well to epithelial layers, produces a protective biofilm, and modulates immune responses. It shows promise in reducing radiation-induced oral mucositis and can be safely used in infant formula. Additionally, a daily dosage of 3×10^9 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects
Read the detailed description
Radiotherapy (RT) is an important treatment for head and neck malignant tumors and can be used alone or in combination with chemotherapy as radical or adjuvant therapy. Despite improvements in RT equipment and techniques, there are still a variety of acute oral complications, including oral mucositis (OM), xerostomia, taste dysfunction, and oral infection. OM is one of the most common acute radiation-related toxicity in head and neck malignant tumor patients receiving RT, and approximately 50~70% of patients experience severe oral mucositis (SOM). The painful inflammation and ulceration associated with OM not only profoundly affect patients' ability to eat, swallow, and speak but also decrease patients' tolerance to anti-cancer treatment, seriously impairing patients' quality of life (QoL) and causing interruptions and cancellations of cancer treatment. Standard treatment for OM focuses on pain control, rehydration, and good oral hygiene. For patients with hematopoietic stem cell transplantation, palifermin (keratinocyte growth factor-1) is recommended. Although some clinical strategies for OM such as non-steroidal anti-inflammatory drugs, mucosal protective agents, growth factors and cytokines, antibacterial, and pain relief drugs have been recommended by the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO), the therapeutic benefit is limited6. Thus, it is crucial to develop effective drugs or treatment strategies to decrease radiation-induced mucosal toxicity.
LGG has been used in clinical trials for the prevention and treatment of oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma (including nasopharyngeal carcinoma). It was isolated from a healthy adult's fecal sample and possesses good growth characteristics and the ability to adhere to epithelial layers. It has long been one of the most extensively researched and applied probiotic strains, utilized in various commercially available probiotic products. Its beneficial effects have been extensively studied in clinical trials and human intervention studies, including its role in preventing and treating gastrointestinal infections and diarrhea, stimulating immune responses, and even preventing certain allergic symptoms.
In addition to producing a biofilm that mechanically protects the mucosa, reduces epithelial cell apoptosis, and maintains cell cytoskeleton integrity, LGG also exhibits immunomodulatory properties. It protects the epithelium from radiation damage by reducing TLR-2/COX-2 activation and regulates the protein levels of pro-inflammatory cytokines tumor necrosis factor-alpha, interleukin-6, and monocyte chemotactic protein-1 in tissues, actively participating in host defense processes. It can also reduce the number of pathogenic bacteria and regulate colony distribution.
The occurrence and development of radiation-induced oral mucositis are closely related to cellular immunity. A series of pro-inflammatory cytokines produced by immune cells such as tumor necrosis factor-alpha and interleukin-6 will positively feedback to amplify the inflammatory response of radiation-induced oral mucositis.
Regarding safety, LGG can be added to infant formula as a probiotic. Furthermore, studies have shown that a dosage of 3×10^9 CFU of LGG per day can be used to treat irritable bowel syndrome (IBS) without causing disease or toxicity in the body. Therefore, Lactobacillus rhamnosus GG holds promise as a potential approach for preventing and treating radiation-induced oral mucositis.
- Conditions
- Oral Mucositis
- Being tested
- Lactobacillus rhamnosus GG, Placebo-containing tablets, Radiotherapy
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GGDietary supplement
Lactobacillus rhamnosus GG powder (Birton Probiotic \& Prebiotic Powder, USA) contained no less than 5×10^9 CFU viable cells of Lactobacillus rhamnosus GG as the active ingredient.
Placebo-containing tabletsDietary supplement
Starch preparations that look and taste like Lactobacillus rhamnosus GG powder
RadiotherapyRadiation
One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy, with radiotherapy using intensity-modulated radiotherapy techniques.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Placebo-containing tablets Receives: Dietary Supplement: Placebo-containing tablets; Radiation: Radiotherapy |
| Experimental group | Experimental | Lactobacillus rhamnosus GG (LGG) Receives: Dietary Supplement: Lactobacillus rhamnosus GG; 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 (WHO grade ≥3)
Oral mucositis is assessed by trained physicians 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
Secondary outcomes (2)
The time to onset of Severe Oral mucositis (WHO grade ≥3)
Time from the first day of radiotherapy to the first determination of SOM. Patients without observed SOM were assigned onset days of 6 or 6.5 weeks
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
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. Patients without observed SOM were assigned a duration of 0 days
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start10 Nov 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies 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
- NCT06390176
- Sponsor's protocol ID
- 2023-1747
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2024
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06390176
- Acronym / sponsor ID
- 2023-1747
- Conditions
- Oral Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 30 Apr 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.
Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients.
Lactobacillus rhamnosus GG (LGG) is a type of lactic acid bacterium, which is an important component of the microbiota in many parts of the human body.
Lactobacillus rhamnosus GG (LGG) is a lactic acid bacterium found in the human body, extensively researched for its probiotic properties. It has been tested in clinical trials for preventing and treating oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma. LGG adheres well to epithelial layers, produces a protective biofilm, and modulates immune responses. It shows promise in reducing radiation-induced oral mucositis and can be safely used in infant formula. Additionally, a daily dosage of 3×10^9 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects
Detailed description
Radiotherapy (RT) is an important treatment for head and neck malignant tumors and can be used alone or in combination with chemotherapy as radical or adjuvant therapy. Despite improvements in RT equipment and techniques, there are still a variety of acute oral complications, including oral mucositis (OM), xerostomia, taste dysfunction, and oral infection. OM is one of the most common acute radiation-related toxicity in head and neck malignant tumor patients receiving RT, and approximately 50~70% of patients experience severe oral mucositis (SOM). The painful inflammation and ulceration associated with OM not only profoundly affect patients' ability to eat, swallow, and speak but also decrease patients' tolerance to anti-cancer treatment, seriously impairing patients' quality of life (QoL) and causing interruptions and cancellations of cancer treatment. Standard treatment for OM focuses on pain control, rehydration, and good oral hygiene. For patients with hematopoietic stem cell transplantation, palifermin (keratinocyte growth factor-1) is recommended. Although some clinical strategies for OM such as non-steroidal anti-inflammatory drugs, mucosal protective agents, growth factors and cytokines, antibacterial, and pain relief drugs have been recommended by the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO), the therapeutic benefit is limited6. Thus, it is crucial to develop effective drugs or treatment strategies to decrease radiation-induced mucosal toxicity.
LGG has been used in clinical trials for the prevention and treatment of oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma (including nasopharyngeal carcinoma). It was isolated from a healthy adult's fecal sample and possesses good growth characteristics and the ability to adhere to epithelial layers. It has long been one of the most extensively researched and applied probiotic strains, utilized in various commercially available probiotic products. Its beneficial effects have been extensively studied in clinical trials and human intervention studies, including its role in preventing and treating gastrointestinal infections and diarrhea, stimulating immune responses, and even preventing certain allergic symptoms.
In addition to producing a biofilm that mechanically protects the mucosa, reduces epithelial cell apoptosis, and maintains cell cytoskeleton integrity, LGG also exhibits immunomodulatory properties. It protects the epithelium from radiation damage by reducing TLR-2/COX-2 activation and regulates the protein levels of pro-inflammatory cytokines tumor necrosis factor-alpha, interleukin-6, and monocyte chemotactic protein-1 in tissues, actively participating in host defense processes. It can also reduce the number of pathogenic bacteria and regulate colony distribution.
The occurrence and development of radiation-induced oral mucositis are closely related to cellular immunity. A series of pro-inflammatory cytokines produced by immune cells such as tumor necrosis factor-alpha and interleukin-6 will positively feedback to amplify the inflammatory response of radiation-induced oral mucositis.
Regarding safety, LGG can be added to infant formula as a probiotic. Furthermore, studies have shown that a dosage of 3×10^9 CFU of LGG per day can be used to treat irritable bowel syndrome (IBS) without causing disease or toxicity in the body. Therefore, Lactobacillus rhamnosus GG holds promise as a potential approach for preventing and treating radiation-induced oral mucositis.
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 | Dietary Supplement: Placebo-containing tablets, Radiation: RadiotherapyPlacebo-containing tablets |
| Experimental group | Experimental | Dietary Supplement: Lactobacillus rhamnosus GG, Radiation: RadiotherapyLactobacillus rhamnosus GG (LGG) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Aged 18-80 years;
- Eastern Cooperative Oncology Group performance status of ≤2;
- Planning to receive definitive RT or postoperative adjuvant RT;
- Normal liver, kidney and bone marrow function;
Key exclusion criteria (6 listed)
- Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
- Those with poor compliance;
- Pregnancy or breastfeeding;
- History of head and neck radiotherapy;
- Taking antifungal or viral medications one week prior to the start of radiation therapy.
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 rhamnosus GGLactobacillus rhamnosus GG powder (Birton Probiotic \& Prebiotic Powder, USA) contained no less than 5×10^9 CFU viable cells of Lactobacillus rhamnosus GG as the active ingredient. | Dietary supplement | Experimental group |
| Placebo-containing tabletsStarch preparations that look and taste like Lactobacillus rhamnosus GG powder | Dietary supplement | Control group |
| RadiotherapyOne of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy, with radiotherapy using intensity-modulated radiotherapy techniques. | Radiation | Control group, Experimental group |
Primary outcome
The incidence of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Oral mucositis is assessed by trained physicians 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.
2 secondary outcomes
The time to onset of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
The duration of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
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 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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 rhamnosus GG and Radiotherapy in people with Oral Mucositis, 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 6 inclusion and 6 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 9 Sep 2026. 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 (WHO grade ≥3) (time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy). 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 9 Sep 2026.