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.
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.
What it found
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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.
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.
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Who cites it
1 citing paper in PubMed.
- Mechanistic pathways predictive modeling and translational interventions for radiation enteritis in cervical cancer radiotherapy.Frontiers in cellular and infection microbiology · 2025Review
Corrections and comments
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Authors and funding
6 authors.
Funding
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.
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Registered trials
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