Dietary Supplements

EFFICACY OF PROBIOTICS IN PREVENTING CHEMOTHERAPY-INDUCED DIARRHEA IN GASTROINTESTINAL CANCER PATIENTS.

TL;DR

Probiotic compared to placebo did not result in a statistically significant effect, suggesting a lack of benefit of administered probiotic for prevention of chemotherapy-induced diarrhea among patients with gastrointestinal cancer.

Key Findings

Probiotic use did not reduce the incidence of grade 2/3 diarrhea episodes compared to placebo in gastrointestinal cancer patients receiving chemotherapy.

  • Grade 2/3 diarrhea occurred in 55.56% of the placebo arm versus 44.44% of the probiotic arm (P=1).
  • 28 patients were randomized 1:1 to receive either placebo or probiotic.
  • Patients received chemotherapy based on fluoropyrimidine, oxaliplatin, and/or irinotecan.
  • Follow-up duration was 90 days.

The overall incidence of diarrhea was not significantly different between the probiotic and placebo groups.

  • Overall diarrhea incidence was 71.43% in the placebo group versus 64.29% in the probiotic group (P=1).
  • No statistically significant difference was observed between the two groups.
  • Patients recorded bowel habits in a diary using the Bristol stool scale.

The median number of diarrhea episodes tended to be lower in the probiotic group but did not reach statistical significance.

  • The median number of diarrhea episodes during the 90-day follow-up was eight episodes in the probiotic group compared to nine episodes in the placebo group.
  • This difference was not statistically significant (P=0.639).

Subgroup analyses failed to identify any specific patient characteristics associated with benefit from probiotic use.

  • No specific patient characteristics were found to be associated with any benefit from probiotic use, regardless of diarrhea grade.
  • The analysis covered the full 90-day follow-up period.

No infections related to the administered probiotic strains were detected during the study.

  • The probiotic contained 20 billion CFU of a five-strain mixture: Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37, Bifidobacterium lactis Bi-04, Bifidobacterium lactis Bi-07, and Bifidobacterium bifidum Bb-02 (335 mg total).
  • No infections associated with any of the probiotic strains administered in the study were detected.
  • The probiotic was administered orally once daily for 90 days.

The study enrolled 28 patients with gastrointestinal cancer between April 2022 and June 2024 who were intended to receive fluoropyrimidine-, oxaliplatin-, and/or irinotecan-based chemotherapy.

  • Patients were randomized in a 1:1 ratio to receive either placebo or 20 billion CFU of the probiotic mixture.
  • The study used a randomized controlled design.
  • Bowel habits were self-recorded in a diary using the Bristol stool scale over 90 days.

Have a question about this study?

Citation

DE Souza G, Araujo Filho H, DE Oliveira C, Paiotti A, Forones N. (2025). EFFICACY OF PROBIOTICS IN PREVENTING CHEMOTHERAPY-INDUCED DIARRHEA IN GASTROINTESTINAL CANCER PATIENTS.. Arquivos de gastroenterologia. https://doi.org/10.1590/S0004-2803.24612025-020