NCT03978949

Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiotherapy
• Toxicity
• Diarrhea
• Probiotics

Interventions

Type	Name	Description
DRUG	Bacillus Licheniformis	Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
DRUG	Placebo	Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-08-31
• Completion: 2024-08-31
• First posted: 2019-06-07
• Last updated: 2021-01-19

Locations

1 site across 1 country: South Korea