Efficacy of a Probiotic and Microbiological Analysis on Oral Complications in Patients With HNC

NCT06122636 | Completed DMC

• 1 other identifier: 22/2021
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a Clinical Trial and the main objective is to Evaluate the effects of probiotics on oral complications induced by antineoplastic therapies in patients with head and neck cancer, attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), Faculty of Medicine and Health Sciences Bellvitge campus during the period 2022- 2024. Research question: Is the use of probiotics compared to placebo effective in reducing oral complications produced by antineoplastic therapies in patients with head and neck cancer attended in the radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet and the Dental Hospital of the University of Barcelona, Faculty of Medicine and Health Sciences campus Bellvitge during the period 2022- 2024? Study population: Patients attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), (Master of Dentistry in Oncology and Immunocompromised Patients) diagnosed by histological confirmation of head and neck cancer and treated in the last year.Intervention: Patients who agree to participate in the study will be randomized to the intervention or control group. Two visits will be made, the first as a baseline measurement and the second after the end of the intervention. In the first visit they will be given the products either probiotic or placebo, with presentation of a box with 10 sachets. The probiotics contain: Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus. 1 x 10e10 Colony Forming Units (CFU). And the placebo composed of excipients. They are gluten free. Each patient will be given 1 sachet dissolved in water, to take 2-3 minutes of mouthfuls then swallow, after brushing, once a day, for 30 days.

Conditions

Quality of Life; Oral Mucositis; Dental Plaque; Periodontal Diseases; Xerostomia; Dysbiosis

Keywords

Radiotherapy; chemotherapy; surgery; probiotics; head and neck cancer

Outcome Measures

Primary Outcomes (6)

• Concentration of oral dysbiosis

  Analyzed through microbiological qPCR study with 16 S sRNA primers, real-time quantitative PCR and comparative analysis with conventional culture looking for changes in the total count of the following periodontopathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Campylobacter rectus, Fusobacterium nucleatum and Candida culture.

  30 days

• Rate of xerostomia

  It will be measured by sialometry, analyzing unstimulated salivary secretion and stimulated salivary secretion

  30 days

• Salivary ph concentration

  It will be measured through paper strips, in one of the containers with accumulated saliva.

  30 days

• Rate of oral mucositis

  It will be measured through a clinical analysis, taking into account the World Health Organization (WHO) mucositis assessment scale.

  30 days

• Periodontitis rate

  Measured by clinical examination according to SEPA (Spanish Society of Periodontology) criteria for the classification of periodontal disease.

  30 days

• Quality of life rate

  It will be analyzed based on the quality of life questionnaire for head and neck cancer patients EORTC QLQ-H\&N35 Spanish version.

  30 days

Study Arms (2)

Experimental group

EXPERIMENTAL

An envelope with the same packaging, size, shape and color will be given, it will only differ from the placebo in that it will contain the active ingredient of the intervention which is Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus.Experimental group

Dietary Supplement: The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory

Placebo group

PLACEBO COMPARATOR

The placebo will be given in an envelope with the same packaging, size, shape and color of contents as the intervention of interest, except that the placebo will not contain the active ingredient of the intervention

Other: Placebo

Interventions

The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory DIETARY_SUPPLEMENT

Each patient should take 1 sachet per day, dissolve it in a glass of water, hold in the mouth for 2-3 minutes and then swallow, for a period of 30 days.

Experimental group

Placebo OTHER

The placebo will be administered in an envelope with the same packaging, size, shape and color of contents as the intervention of interest, except that the placebo will not contain the active ingredient of the intervention.

Placebo group

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age.
• Who give informed consent to participate in the study.
• With histologic diagnosis of head and neck cancer.
• Treated within the last year for head and neck cancer.

You may not qualify if:

• Patients who do not wish to participate in the study.
• Patients with osteonecrosis.
• Inability to take oral medications.
• Allergic to probiotics.
• On active antibiotic treatment or having received antibiotic treatment in the last thirty days.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

University of Barcelona

Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Stomatitis; Dental Plaque; Periodontal Diseases; Xerostomia; Dysbiosis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases; Salivary Gland Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• Tanya Pereira Riveros, Msc

  Universuty of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 8, 2023
• Study Start: October 3, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

ES (1)