drugset / Trial / NCT03978949

Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

NCT03978949 ↗

Phase 3 Unknown 248 enrolled Asan Medical Center
RandomizedParallel-groupDouble-blindPrevention

Summary

In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.

Timeline

Start
2019-06-01
Primary completion
2021-08-31
Completion
2024-08-31

Outcome

Missed primary endpoint

paper indicating that probiotics failed in their preventive role compared with placebo (p = 0.493). PMID 39451742 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacillus Licheniformis Unknown — —

Indications