Head-and-neck CancerPhase 2NCT03552458
Effects of Probiotics in Preventing Oral Mucositis
A Phase 2 study testing Lactobacillus Reuteri Oral Solution [BioGaia] in people with Head-and-neck Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The study will be a randomized double blind prospective placebo controlled clinical study and aims to determine the therapeutic efficacy of Probiotics in Oral Mucositis pathogenesis in patients undergoing head and neck radiotherapy. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Head-and-neck Cancer
- What is being tested?
- Lactobacillus Reuteri Oral Solution [BioGaia]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Jun 2018to Jun 2021
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are 21 years of age or older
- histological diagnosis of head and neck carcinoma available
- undergoing head and neck radiotherapy of at least 6000cGY
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- no known allergy to Biogaia
- able to give written informed consent, or have written consent given on their behalf.
Who cannot join
- patients who cannot use the products or have it administered to them
- patients with existing conditions predisposing to oral ulcer formation
- patients with mucositis at baseline (prior to initiation of treatment)
- previous radiotherapy to the head and neck region
- female patients who are pregnant or breastfeeding
- patients who have central venous catheters
Show all 11Show fewer
- patients who have impaired intestinal epithelial barrier
- patients who have cardiac valvular disease
- unable to give written informed consent, or are unable to have written consent given on their behalf.
- inability to converse in English or Mandarin
- severe immunosuppression (Absolute Neutrophil Count of less than 1500 cells/µL)
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital, Singapore
Singapore
Catherine Hong, BDS, 67795555 ext. 1787, denchhl@nus.edu.sg
Catherine Hong, BDS
About this study
Official title: Effects of Probiotics Intake on Oral Microbiome and Mucosa Inflammation in Patients With Cytotoxic Therapy Induced Oral Mucositis: A Pilot Study
The study will be a randomized double blind prospective placebo controlled clinical study and aims to determine the therapeutic efficacy of Probiotics in Oral Mucositis pathogenesis in patients undergoing head and neck radiotherapy.
Read the detailed description
The study will be a randomized double blind prospective placebo controlled clinical study (Clinical Trial phase II) of 50 patients (25 in LR group, 25 in placebo group) with a confirmed cancer diagnosis requiring head and neck radiotherapy with a minimum dose of 6000cGy.
Patients will be randomly assigned to either of the treatment arms in a 1:1 ratio. The active agent; Lactobacillus reuteri Prodentis (Biogaia ®) will be supplied in droplet form by Pharma forte Singapore Pte Ltd and dosage used will be as recommended by manufacturer (5 drops/time twice a day which is equivalent to 4 X 108 CFU of live bacteria). The control agent will be identical in physical appearance and color to the study agent and will be made by the manufacturer.
Patients assigned to either LR group or placebo group will start from the first day of radiotherapy and continued until 2-week post radiation (approximately 8-9 weeks). Patients will be instructed to use the LR droplets twice a day according to manufacturer's instructions; once in the morning after breakfast and the other just before bedtime and to avoid any food/drinks 30 minutes before and after usage. Compliance with treatment will be elicited and recorded.
The dose selection is based on manufacturer's recommendations and is safe for use during pregnancy and breastfeeding. However, this is not an issue in this population as none of the patients should be pregnant or breastfeeding while receiving radiation and anti-neoplastic chemotherapy.
The PI will serve as the auditor for data quality assurance on a quarterly basis.Data collected on paper will be stored in the principal investigator's locked cabinet. Data will be entered into Microsoft Excel™ (2007) and double entered for accuracy. Data will be kept in a password secured portable computer and backed up to dedicated local back-up drive every week. Only group statistics will be reported. The database will only be accessible to investigators involved in and approved for the study. All data will be kept for 6 years after study completion to access data for publication of the work done, after which data will be destroyed.
- Conditions
- Head-and-neck Cancer
- Being tested
- Lactobacillus Reuteri Oral Solution [BioGaia], Placebos
- Keywords
- oral mucositis, probiotics, anti-neoplastic chemotherapy
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Reuteri Oral Solution [BioGaia]Drug
Also called Biogaia Prodentis
BioGaia Lactobacillus Reuteri drops
PlacebosDrug
Also called Placebo
Placebo will be identical in physical appearance and color to the study agent and will be made by the manufacturer
| Study group | Role | What they receive |
|---|---|---|
| LR group | Experimental | Lactobacillus Reuteri Oral Solution [BioGaia] Receives: Drug: Lactobacillus Reuteri Oral Solution [BioGaia] |
| Placebo group | Placebo comparator | Placebos: The control agent will not contain the active agent Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Mucositis (OM) Severity Assessment
To assess the severity of OM using Oral Mucositis Assessment Scale (OMAS)
Measured: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
Oral Mucositis (OM) Severity Assessment
To assess the severity of OM (Grade 0-4) using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Measured: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
Duration of Oral Mucositis (OM)
To assess the number of days of OM experienced i.e. start of OM still resolution of OMM
Measured: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
Pain Severity of OM
Visual Analogue Scale (0-10)
Measured: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
Quality of Life post Radiation
Composite score using the Oral Mucositis Daily Questionnaire (8 Item questionnaire)
Measured: Daily Patient Completed Questionnaire from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
Secondary outcomes (1)
Oral Bacteria Analysis and Gene Expression Analysis
Oral samples will be collected at 2 time points: baseline (before start of head and neck radiotherapy) and at week 4 (Visit 5, midpoint) of radiotherapy.
Measured: Change between baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start26 Jun 2018
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head-and-neck CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Model description
- randomized double blind prospective placebo controlled clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Hong, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552458
- Sponsor's protocol ID
- 2017/00508
- Other IDs
- 2017
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goh CE, Williams R, Gupta N, Ho F, Islam I, Lai CWM, Tan KS, Hong CHL. Effect of Limosilactobacillus reuteri Probiotic on Oral Mucositis in Patients Undergoing Head and Neck Radiation: A Randomised Trial. Oral Dis. 2026 Feb;32(2):480-491. doi: 10.1111/odi.70083. Epub 2025 Aug 31.
PubMed 40887814
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics Intake on Oral Microbiome and Mucosa Inflammation in Patients With Cytotoxic Therapy Induced Oral Mucositis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03552458
- Acronym / sponsor ID
- 2017/00508
- Conditions
- Head-and-neck Cancer
- Keywords
- oral mucositis, probiotics, anti-neoplastic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 11 Jun 2018 (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.
The study will be a randomized double blind prospective placebo controlled clinical study and aims to determine the therapeutic efficacy of Probiotics in Oral Mucositis pathogenesis in patients undergoing head and neck radiotherapy.
Detailed description
The study will be a randomized double blind prospective placebo controlled clinical study (Clinical Trial phase II) of 50 patients (25 in LR group, 25 in placebo group) with a confirmed cancer diagnosis requiring head and neck radiotherapy with a minimum dose of 6000cGy.
Patients will be randomly assigned to either of the treatment arms in a 1:1 ratio. The active agent; Lactobacillus reuteri Prodentis (Biogaia ®) will be supplied in droplet form by Pharma forte Singapore Pte Ltd and dosage used will be as recommended by manufacturer (5 drops/time twice a day which is equivalent to 4 X 108 CFU of live bacteria). The control agent will be identical in physical appearance and color to the study agent and will be made by the manufacturer.
Patients assigned to either LR group or placebo group will start from the first day of radiotherapy and continued until 2-week post radiation (approximately 8-9 weeks). Patients will be instructed to use the LR droplets twice a day according to manufacturer's instructions; once in the morning after breakfast and the other just before bedtime and to avoid any food/drinks 30 minutes before and after usage. Compliance with treatment will be elicited and recorded.
The dose selection is based on manufacturer's recommendations and is safe for use during pregnancy and breastfeeding. However, this is not an issue in this population as none of the patients should be pregnant or breastfeeding while receiving radiation and anti-neoplastic chemotherapy.
The PI will serve as the auditor for data quality assurance on a quarterly basis.Data collected on paper will be stored in the principal investigator's locked cabinet. Data will be entered into Microsoft Excel™ (2007) and double entered for accuracy. Data will be kept in a password secured portable computer and backed up to dedicated local back-up drive every week. Only group statistics will be reported. The database will only be accessible to investigators involved in and approved for the study. All data will be kept for 6 years after study completion to access data for publication of the work done, after which data will be destroyed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blind prospective placebo controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| LR group | Experimental | Drug: Lactobacillus Reuteri Oral Solution [BioGaia]Lactobacillus Reuteri Oral Solution [BioGaia] |
| Placebo group | Placebo comparator | Drug: PlacebosPlacebos: The control agent will not contain the active agent |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients who are 21 years of age or older
- histological diagnosis of head and neck carcinoma available
- undergoing head and neck radiotherapy of at least 6000cGY
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- no known allergy to Biogaia
Key exclusion criteria (11 listed)
- patients who cannot use the products or have it administered to them
- patients with existing conditions predisposing to oral ulcer formation
- patients with mucositis at baseline (prior to initiation of treatment)
- previous radiotherapy to the head and neck region
- female patients who are pregnant or breastfeeding
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 Oral Solution [BioGaia]Also: Biogaia ProdentisBioGaia Lactobacillus Reuteri drops | Drug | LR group |
| PlacebosAlso: PlaceboPlacebo will be identical in physical appearance and color to the study agent and will be made by the manufacturer | Drug | Placebo group |
Primary outcome
Oral Mucositis (OM) Severity Assessment
Time frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
To assess the severity of OM using Oral Mucositis Assessment Scale (OMAS)
Oral Mucositis (OM) Severity Assessment
Time frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
To assess the severity of OM (Grade 0-4) using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Duration of Oral Mucositis (OM)
Time frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
To assess the number of days of OM experienced i.e. start of OM still resolution of OMM
Pain Severity of OM
Time frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
Visual Analogue Scale (0-10)
Quality of Life post Radiation
Time frame: Daily Patient Completed Questionnaire from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
Composite score using the Oral Mucositis Daily Questionnaire (8 Item questionnaire)
1 secondary outcome
Oral Bacteria Analysis and Gene Expression Analysis
Time frame: Change between baseline and Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Derived from this study: PubMed 40887814Goh CE, Williams R, Gupta N, Ho F, Islam I, Lai CWM, Tan KS, Hong CHL. Effect of Limosilactobacillus reuteri Probiotic on Oral Mucositis in Patients Undergoing Head and Neck Radiation: A Randomised Trial. Oral Dis. 2026 Feb;32(2):480-491. doi: 10.1111/odi.70083. Epub 2025 Aug 31.
- 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.
Catherine Hong principal investigator
National University Hospital, Singapore
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 Oral Solution [BioGaia] in people with Head-and-neck Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 11 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: status not confirmed, as of the sponsor's last update on 30 Apr 2019. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Hong, Master (65-6779 5555 ext. 1787, denchhl@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Mucositis (OM) Severity Assessment (time frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03552458, which also lists 1 linked publication.
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 30 Apr 2019.