Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2018-06-26
2021-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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LR group
Lactobacillus Reuteri Oral Solution \[BioGaia\]
Lactobacillus Reuteri Oral Solution [BioGaia]
BioGaia Lactobacillus Reuteri drops
Placebo group
Placebos: The control agent will not contain the active agent
Placebos
Placebo will be identical in physical appearance and color to the study agent and will be made by the manufacturer
Interventions
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Lactobacillus Reuteri Oral Solution [BioGaia]
BioGaia Lactobacillus Reuteri drops
Placebos
Placebo will be identical in physical appearance and color to the study agent and will be made by the manufacturer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. histological diagnosis of head and neck carcinoma available
3. undergoing head and neck radiotherapy of at least 6000cGY
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
5. no known allergy to Biogaia
6. able to give written informed consent, or have written consent given on their behalf.
Exclusion Criteria
2. patients with existing conditions predisposing to oral ulcer formation
3. patients with mucositis at baseline (prior to initiation of treatment)
4. previous radiotherapy to the head and neck region
5. female patients who are pregnant or breastfeeding
6. patients who have central venous catheters
7. patients who have impaired intestinal epithelial barrier
8. patients who have cardiac valvular disease
9. unable to give written informed consent, or are unable to have written consent given on their behalf.
10. inability to converse in English or Mandarin
11. severe immunosuppression (Absolute Neutrophil Count of less than 1500 cells/µL)
21 Years
99 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Catherine Hong
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital, Singapore
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Catherine Hong, BDS
Role: primary
References
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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. 2025 Aug 31. doi: 10.1111/odi.70083. Online ahead of print.
Other Identifiers
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2017/00508
Identifier Type: -
Identifier Source: org_study_id