Effects of Probiotics in Preventing Oral Mucositis

NCT03552458 | Unknown Phase 2 DMC

• 1 other identifier: 2017/00508
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head-and-neck Cancer

Keywords

oral mucositis; probiotics; anti-neoplastic chemotherapy

Outcome Measures

Primary Outcomes (5)

• Oral Mucositis (OM) Severity Assessment

  To assess the severity of OM using Oral Mucositis Assessment Scale (OMAS)

  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

  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

  Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment

• Pain Severity of OM

  Visual Analogue Scale (0-10)

  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)

  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

  Change between baseline and Week 4

Study Arms (2)

LR group

EXPERIMENTAL

Lactobacillus Reuteri Oral Solution \[BioGaia\]

Drug: Lactobacillus Reuteri Oral Solution [BioGaia]

Placebo group

PLACEBO COMPARATOR

Placebos: The control agent will not contain the active agent

Drug: Placebos

Interventions

Lactobacillus Reuteri Oral Solution [BioGaia] DRUG

BioGaia Lactobacillus Reuteri drops

Also known as: Biogaia Prodentis

LR group

Placebos DRUG

Placebo will be identical in physical appearance and color to the study agent and will be made by the manufacturer

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital, Singapore

Singapore, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 40887814 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Catherine Hong

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Hong, Master

CONTACT

65-6779 5555; denchhl@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized double blind prospective placebo controlled clinical study

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: June 11, 2018
• Study Start: June 26, 2018
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)