Evidence map›Paper›PMID 34530750›Full record

ArticleBMC cancer2021

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

Yeon Joo Kim, Jesang Yu, Sung Pyo Park, Seung Hae Lee, Young Seok Kim

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03978949 (Prevention of Radiotherapy Induced Enteropathy by Probiotics), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03978949 phase3unknown statusnot on this map

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

TypeinterventionalSponsorAsan Medical CenterRan2019 to 2024Enrolled248ConditionsRadiotherapy, Toxicity, Diarrhea, ProbioticsArmsBacillus Licheniformis, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Appraisal of postbiotics in cancer therapy.Frontiers in pharmacology · 2024
    Review
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Yeon Joo Kim *Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea.
Jesang Yu *Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea.
Sung Pyo ParkDepartment of Ophthalmology, Kangdong Sacred Heart Hospital, Hallym University, College of Medicine, Gangdong-Gu, Seoul, 05355, Republic of Korea.
Seung Hae LeeDepartment of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea.
Young Seok KimDepartment of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea. ysk@amc.seoul.kr.ORCID http://orcid.org/0000-0003-4739-4476
Ulsan College · KRHallym University · KR

Funding

Binex Korea 2019-0696
6 · The paper itself

Abstract

backgroundRadiation 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.

methodsThis 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.

trial registrationClinicalTrials.gov ( NCT03978949 , Registered on 7 June 2019).

Indexed as

Double-Blind MethodFemaleGenital Neoplasms, FemaleHumansIncidenceIntestinal DiseasesMalePlacebosProbioticsProspective StudiesRadiation InjuriesRandomized Controlled Trials as TopicRepublic of KoreaUrologic NeoplasmsPlacebosEfficacyEnteropathyProbioticsRadiotherapySafety

Identifiers

PMID34530750
PMCPMC8444386
OpenAlexW3200357885

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.