Evidence map›Paper›PMID 20444243›Full record

Trial reportRadiation oncology (London, England)2010

Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients.

Imjai Chitapanarux, Taned Chitapanarux, Patrinee Traisathit, Sudkaneung Kudumpee, Ekkasit Tharavichitkul, Vicharn Lorvidhaya

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Radiation oncology (London, England), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01790035 (A Phase I and Randomized Controlled Phase II Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer), which is not on this map. Cited by 110 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 17 pooled it
4.8field-weighted citation impact, top 5% 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.

NCT01790035 phase1terminatednot on this mapstarted 2014, after this paper: background citation

A Phase I and Randomized Controlled Phase II Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer

TypeinterventionalSponsorWashington University School of MedicineRan2014 to 2021Enrolled23ConditionsGastrointestinal NeoplasmsArmsLGG, Placebo
3 · Its place in the literature

Who cites it

110 citing papers in PubMed, 17 syntheses or guidelines pooled it, 255 citations in OpenAlex.

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  13. Systematic Review: The Impact of Cancer Treatment on the Gut and Vaginal Microbiome in Women With a Gynecological Malignancy.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2017
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  16. Systematic review of agents for the management of gastrointestinal mucositis in cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2013
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  18. Impact of Saccharomyces boulardii on acute gastrointestinal toxicities in patients undergoing pelvic radiotherapy for gynecologic cancers: a randomized controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
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  19. A phase II clinical trial ofFrontiers in nutrition · 2025
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50 more citing papers are in PubMed but not listed here.

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

6 authors at 1 institution in 1 country.

Imjai ChitapanaruxDepartment of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com
Taned Chitapanarux
Patrinee Traisathit
Sudkaneung Kudumpee
Ekkasit Tharavichitkul
Vicharn Lorvidhaya
Chiang Mai University · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadiation-induced diarrhea is frequently observed during pelvic radiotherapy. This study was performed to determine the ability of a probiotic containing live lactobacillus acidophilus plus bifidobacterium bifidum to reduce the incidence of radiation-induced diarrhea in locally advanced cervical cancer patients.

methodsPatients who were undergoing pelvic radiotherapy concurrent with weekly cisplatin were randomly assigned to a study drug or placebo, in a double-blind study. Diarrhea was graded weekly according the Common Toxicity Criteria (CTC) system. Stool consistency and white and red blood cell count in stool were also assessed. The primary endpoint was to reduce the incidence of diarrhea, defined by a CTC grade 2 or more, and the need for anti-diarrheal medication.

resultsA total of 63 patients were enrolled. Grade 2 -3 diarrhea was observed in 45% of the placebo group (n = 31) and 9% of the study drug group (n = 32) (p = 0.002). Anti-diarrheal medication use was significantly reduced in the placebo group (p = 0.03). The patients in the study drug group had a significantly improved stool consistency (p < 0.001).

conclusionsLive lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency.

Indexed as

Administration, OralAdolescentAdultAgedBifidobacteriumCarcinoma, Squamous CellDiarrheaDouble-Blind MethodFemaleHumansIncidenceLactobacillus acidophilusMiddle AgedPelvic NeoplasmsPlacebosProbioticsPlacebos

Identifiers

PMID20444243
PMCPMC2874795
OpenAlexW2109331652

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.