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
Results
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.
Results
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.
Results
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).
Results
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.
Results
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.
Methods
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.
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