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Prevention of radiotherapy induced enteropathy by probiotics (PREP): protocol for a double-blind randomized placebo-controlled trial

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Abstract
Background: Radiation induced enteropathy is a common complication of radiotherapy for pelvic tumors and adversely affects patient quality of life. Probiotics are thought to restore bowel microflora to optimal levels and reinforce intestinal barrier capacity. Although probiotics are effective in the treatment of radiation induced enteropathy, less is known about their efficacy to prevent radiation induced enteropathy.

Methods: This double-blind randomized placebo-controlled study will investigate the efficacy of probiotics to prevent radiation-induced enteropathy in patients with gynecologic or urologic cancer who received pelvic radiotherapy. The study is designed to enroll 248 eligible patients, who will be randomized 1:1 to a probiotic or placebo group. Toxicities will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Discussion: The primary aim of this study is to provide high level evidence for the ability of probiotics to prevent acute radiation induced enteropathy. The secondary aims are to determine the effects of probiotics on the incidence of chronic radiation induced enteropathy and the safety of probiotics in patients with gynecologic or urologic cancer.
Author(s)
김연주유제상박성표이승해김영석
Issued Date
2021
Type
Article
Keyword
Clinical trialsEfficacyEnteropathyMicrobiota (Symbiotic organisms)ProbioticsRadiationRadiotherapyResearchSafety
DOI
10.1186/s12885-021-08757-w
URI
https://oak.ulsan.ac.kr/handle/2021.oak/7398
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_doaj_primary_oai_doaj_org_article_8ce048104fe3410f9257689fdd944657&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Prevention%20of%20radiotherapy%20induced%20enteropathy%20by%20probiotics%20(PREP):%20protocol%20for%20a%20double-blind%20randomized%20placebo-controlled%20trial&offset=0&pcAvailability=true
Publisher
BMC CANCER
Location
영국
Language
영어
ISSN
1471-2407
Citation Volume
21
Citation Number
1
Citation Start Page
0
Citation End Page
0
Appears in Collections:
Medicine > Medicine
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