Effectiveness of probiotics against oral mucositis

Unblinded, randomized, parallel-group, comparative study on prevention of oral complications by using a probiotic lozenge in chemotherapy patien ts with breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061210028

Enrollment

Registered

2021-08-03

Start date

2021-08-24

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Breast cancer

Interventions

(Ingest group) One ProDentis MUM tablet is dissolved in the bowl twice a day during breakfast and after meals. Always check the patient diary to make sure it has not been taken. Check the box after ea

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age 20 years or older at the time of obtaining consent 2.Those who are scheduled to receive chemotherapy for breast cancer. (docetaxel therapy : using docetaxel or TC therapy: using paclitaxel and carboplatin, not limited to the first treatment) 3.Those who have Grade 1 or less of oral mucositis due to other chemotherapeutic agents within the pre-observation period. 4.Those who can provide written consent for participation in this study

Exclusion criteria

Exclusion criteria: 1.Those who have taken a probiotic preparation within the last 3 months prior to the start of the study.(General lactic acid bacteria preparations such as yogurt are excluded.) 2.Those who have had serious side effects with probiotic pre parations in the past 3.Those who develop oral mucositis due to physical irritation such as dental caries, non-conforming prosthesis 4.Any person who, while participating in this research, participates in any other clinical research using the food or research procedures being studied 5.Any other person deemed inappropriate by the principal investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
Determining the severity of oral mucositis based on NCI-CTCAE ver5.0	—

Secondary

Measure	Time frame
Pain scale numerical rating scale (NRS) Score the oral cavity using two oral assessments PISA: Periodontal inflamed surface area Number of oral bacteria Oral dryness (saliva test and mucus measurement) Time to first appearance of oral mucositis (using the patient diary record) Duration of each grade of oral mucositis (Evaluation by a single evaluator using patient diary records) Oral microbiome analysis (Saliva and gingival plaque from all subjects) Inflammatory cytokines in saliva	—

Measure

Time frame

Pain scale numerical rating scale (NRS) Score the oral cavity using two oral assessments PISA: Periodontal inflamed surface area Number of oral bacteria Oral dryness (saliva test and mucus measurement) Time to first appearance of oral mucositis (using the patient diary record) Duration of each grade of oral mucositis (Evaluation by a single evaluator using patient diary records) Oral microbiome analysis (Saliva and gingival plaque from all subjects) Inflammatory cytokines in saliva

—

Contacts

Public ContactHiromi Nishi

Hiroshima University hospital

hiyoko@hiroshima-u.ac.jp+81-82-257-5744

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026