Impact of Saccharomyces boulardii on acute gastrointestinal toxicities in patients undergoing pelvic radiotherapy for gynecologic cancers: a randomized controlled trial.
- 2025-06-17
- Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 33(7)
- Pooriwat Muangwong
- Ekkasit Tharavichitkul
- Parameth Thiennimitr
- Imjai Chitapanarux
- Kittikun Kittidachanan
- Taned Chitapanarux
- PubMed: 40526282
- DOI: 10.1007/s00520-025-09663-8
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 60
- Population
- 60 patients undergoing pelvic radiotherapy for cervical and endometrial cancers
- Methods
- prospective, randomized, double-blind, controlled trial; S. boulardii (250 mg/day) or placebo, starting one week before radiotherapy and continuing throughout treatment
- Blinding
- Double-blind
- Funding
- Unclear
Purpose
Acute 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.Methods
A 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.Results
S. 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.Conclusion
No 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 registration
The study was registered with the Thai Clinical Trials Registry (TCTR20210204013) on 04 February 2021.Research Insights
S. boulardii significantly reduced the incidence of type 6 and 7 stool consistency at week 3 (p = 0.01).
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 250 mg/day
the treatment group experienced a significantly higher incidence of diarrhea at week 4 compared to the control group (p = 0.03).
- Effect
- Harmful
- Effect size
- Small
- Dose
- 250 mg/day
Overall, no significant differences were found between the groups in terms of ... anti-diarrheal medication use
- Effect
- Neutral
- Effect size
- Small
- Dose
- 250 mg/day
Overall, no significant differences were found between the groups in terms of cumulative GI toxicities
- Effect
- Neutral
- Effect size
- Small
- Dose
- 250 mg/day
Adverse Events Reported
the treatment group experienced a significantly higher incidence of diarrhea at week 4 compared to the control group (p=0.03)
- Finding
- Increased risk
- Significant
- Yes
no significant differences were found between the groups in terms of ... anti-diarrheal medication use
- Finding
- No significant difference
- Significant
- No
Overall, no significant differences were found between the groups in terms of cumulative GI toxicities
- Finding
- No significant difference
- Significant
- No