CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 160 enrolled
Drug / intervention
Streptococcus salivarius K12 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05918224
NCT05918224Phase 2Completed
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Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy for Head and Neck Tumor: A Randomized, Placebo-Controlled, Double-Blind Trial

West China Hospital·interventional·Posted Jun 26, 2023·Updated Feb 5, 2024

In Brief

A Phase 2 clinical trial evaluating Streptococcus salivarius K12 and Streptococcus salivarius K12 simulants for Head and Neck Squamous Cell Carcinoma. Completed, enrolled 160 participants across 1 site.

Detailed Summary

To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Squamous Cell Carcinoma
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 26, 2023
Enrollment StartJan 1, 2022
Primary CompletionNov 30, 2022
TodayJul 1, 2026
Enrollment to primary: 11 monthsPosted 3.0 years ago

Interventions

Streptococcus salivarius K12drug

The patients in intervention group were treated with Streptococcus salivarius K12 lozenges three times a day after gargling from the first day of radiotherapy up to 1 week after the end of treatment. Streptococcus salivarius K12 is dissolved in the mouth and then swallowed.

Streptococcus salivarius K12 simulantsdrug

Patients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group.