Clinical trial · Interventional
Efficacy of a Probiotic and Microbiological Analysis on Oral Complications in Patients With HNC
Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With Head and Neck Cancer: Randomized Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dental Plaque | — | UNRESOLVED | — |
| Dysbiosis | — | UNRESOLVED | — |
| Oral Mucositis | — | UNRESOLVED | — |
| Periodontal Diseases | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- 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
- interventionNames
- Dietary Supplement: The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- 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
- interventionNames
- Other: Placebo
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available