Evidence map›Paper›PMID 40526282›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025

Impact of Saccharomyces boulardii on acute gastrointestinal toxicities in patients undergoing pelvic radiotherapy for gynecologic cancers: a randomized controlled trial.

Pooriwat Muangwong, Ekkasit Tharavichitkul, Parameth Thiennimitr, Imjai Chitapanarux, Kittikun Kittidachanan, Taned Chitapanarux

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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.

Pooriwat MuangwongDivision of Radiation Oncology, Department of Radiation, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Ekkasit TharavichitkulDivision of Radiation Oncology, Department of Radiation, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Parameth ThiennimitrDepartment of Microbiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Imjai ChitapanaruxDivision of Radiation Oncology, Department of Radiation, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Kittikun KittidachananDivision of Radiation Oncology, Department of Radiation, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Taned ChitapanaruxGastrohepatology Unit, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. taned.chi@cmu.ac.th.

Funding

Faculty of Medicine, Chiang Mai University 25-2565
6 · The paper itself

Abstract

purposeAcute gastrointestinal (GI) toxicities are common side effects of pelvic radiotherapy in gynecologic cancers. Although bacterial probiotics show promise, there is limited evidence for yeast-based probiotics such as Saccharomyces boulardii. This study aimed to evaluate the efficacy of S. boulardii in preventing acute radiation-induced GI toxicities in patients undergoing pelvic radiotherapy for cervical and endometrial cancers.

methodsA prospective, randomized, double-blind, controlled trial was conducted with 60 patients receiving definitive or postoperative pelvic radiotherapy. Patients were randomized to receive either S. boulardii (250 mg/day) or a placebo, starting one week before radiotherapy and continuing throughout treatment. Acute GI toxicities were assessed weekly using the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Stool consistency and inflammatory markers were also monitored. The primary outcome was the reduction in the severity of diarrhea and other GI symptoms.

resultsS. boulardii significantly reduced the incidence of type 6 and 7 stool consistency at week 3 (p = 0.01). However, despite this transient improvement, the treatment group experienced a significantly higher incidence of diarrhea at week 4 compared to the control group (p = 0.03). Overall, no significant differences were found between the groups in terms of cumulative GI toxicities or anti-diarrheal medication use, with diarrhea remaining the most common acute GI toxicity in both groups.

conclusionNo consistent effect of S. boulardii was observed across the measured outcomes, and its overall efficacy in preventing acute radiation-induced enteritis remains inconclusive. Further studies with larger sample sizes are warranted.

trial registrationThe study was registered with the Thai Clinical Trials Registry (TCTR20210204013) on 04 February 2021.

Indexed as

Endometrial NeoplasmsGastrointestinal DiseasesProbioticsRadiation InjuriesSaccharomyces boulardiiUterine Cervical NeoplasmsAdultAgedDiarrheaDouble-Blind MethodFemaleHumansMiddle AgedProspective StudiesCervical cancerDiarrheaEndometrial cancerGastrointestinal toxicityPelvic radiotherapyProbioticsSaccharomyces boulardii

Identifiers

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Registered trials

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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.