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Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

NCT03978949 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2021-01-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Young Seok Kim, M.D., Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978949 on ClinicalTrials.gov