drugset / Trial / NCT03978949
Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)
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 ↗
Publications
- Jo YY, Kim YJ, Lee SH, Kim YS. Prevention of Radiotherapy-Induced Enteropathy by Probiotics (PREP): Double-Blind Randomized Placebo-Controlled Trial. Curr Oncol. 2024 Oct 1;31(10):5889-5895. doi: 10.3390/curroncol31100438.
- Kim YJ, Yu J, Park SP, Lee SH, Kim YS. Prevention of radiotherapy induced enteropathy by probiotics (PREP): protocol for a double-blind randomized placebo-controlled trial. BMC Cancer. 2021 Sep 16;21(1):1032. doi: 10.1186/s12885-021-08757-w.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacillus Licheniformis | Unknown | — | — |