The effect of postbiotic mouthwash on oral mucositis associated with chemotherapy with 5-FU based chemotherapy

The effect of postbiotic mouthwash spray compared with 0.65% saline spray on the severity of chemotherapy-induced oral mucositis in adult patients with gastrointestinal cancers receiving 5-fluorouracil, a triple-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250804066751N1

Enrollment

Registered

2026-03-16

Start date

2026-04-04

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer patients receiving 5-fluorouracil–based chemotherapy with oral mucositis. Malignant neoplasm of colon

Interventions

Intervention 1: Intervention group: Patients in the intervention group receive a postbiotic mouthwash containing lysates of Lactobacillus plantarum and Lactobacillus johnsonii. The mouthwash is gargle

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Being at the age of 18 years old and older Patients receiving treatment with a 5-fluorouracil–based chemotherapy regimen

Exclusion criteria

Exclusion criteria: recent oral and dental diseases history

Design outcomes

Primary

Measure	Time frame
Incidence of oral mucositis. Timepoint: Weekly for 4 weeks and once at one month after the intervention. Method of measurement: WHO stomatitis grading 0–4, discrete quantitative variable, To assess the severity of stomatitis, the World Health Organization (WHO) Oral Toxicity Scale, a four-grade clinical grading system, will be utilized. This scale categorizes the severity of oral symptoms and their impact on the ability to nourish into four grades, from zero to four. It is an observational assessment (clinician-related) performed by a trained physician or researcher.	—

Measure

Time frame

Incidence of oral mucositis. Timepoint: Weekly for 4 weeks and once at one month after the intervention. Method of measurement: WHO stomatitis grading 0–4, discrete quantitative variable, To assess the severity of stomatitis, the World Health Organization (WHO) Oral Toxicity Scale, a four-grade clinical grading system, will be utilized. This scale categorizes the severity of oral symptoms and their impact on the ability to nourish into four grades, from zero to four. It is an observational assessment (clinician-related) performed by a trained physician or researcher.

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Secondary

Measure	Time frame
Oral pain severity in patients receiving 5-fluorouracil–based chemotherapy. Timepoint: Weekly for 4 weeks and once at one month after the intervention. Method of measurement: 0–10 Likert scale, patient-reported.;The duration of oral mucositis in patients receiving 5-fluorouracil–based chemotherapy. Timepoint: Weekly for 4 weeks and once at one month after the intervention. Method of measurement: Number of days with mucositis, based on clinical examination.;Any changes in the chemotherapy protocol of patients. Timepoint: Weekly for 4 weeks and once at one month after the intervention. Method of measurement: Review of patient treatment records and documentation of changes.	—

Measure

Time frame

Oral pain severity in patients receiving 5-fluorouracil–based chemotherapy. Timepoint: Weekly for 4 weeks and once at one month after the intervention. Method of measurement: 0–10 Likert scale, patient-reported.;The duration of oral mucositis in patients receiving 5-fluorouracil–based chemotherapy. Timepoint: Weekly for 4 weeks and once at one month after the intervention. Method of measurement: Number of days with mucositis, based on clinical examination.;Any changes in the chemotherapy protocol of patients. Timepoint: Weekly for 4 weeks and once at one month after the intervention. Method of measurement: Review of patient treatment records and documentation of changes.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Kazemi Sormoli

Islamic Azad University

Mhnzkzm7979@gmail.com+98 51 3523 2349

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026