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

NCT06122636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-04-03

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • University of Barcelona

    lead OTHER

Principal Investigators

  • Tanya Pereira Riveros, Msc · Universuty of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06122636 on ClinicalTrials.gov