Effects of Probiotics in Preventing Oral Mucositis
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|ClinicalTrials.gov Identifier: NCT03552458|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head-and-neck Cancer||Drug: Lactobacillus Reuteri Oral Solution [BioGaia] Drug: Placebos||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized double blind prospective placebo controlled clinical study|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Probiotics Intake on Oral Microbiome and Mucosa Inflammation in Patients With Cytotoxic Therapy Induced Oral Mucositis: A Pilot Study|
|Actual Study Start Date :||June 26, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: LR group
Lactobacillus Reuteri Oral Solution [BioGaia]
Drug: Lactobacillus Reuteri Oral Solution [BioGaia]
BioGaia Lactobacillus Reuteri drops
Other Name: Biogaia Prodentis
Placebo Comparator: Placebo group
Placebos: The control agent will not contain the active agent
Placebo will be identical in physical appearance and color to the study agent and will be made by the manufacturer
Other Name: Placebo
- 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)
- Oral Bacteria Analysis and Gene Expression Analysis [ Time Frame: Change between baseline and Week 4 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552458
|Contact: Catherine Hong, Master||65-6779 5555 ext firstname.lastname@example.org|
|National University Hospital, Singapore||Recruiting|
|Contact: Catherine Hong, BDS 67795555 ext 1787 email@example.com|
|Principal Investigator: Catherine Hong, BDS|
|Principal Investigator:||Catherine Hong||National University Hospital, Singapore|