Evidence map›Paper›PMID 41379184›Full record

Trial reportArquivos de gastroenterologia2025

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

Gabriel Caio DE Souza, Humberto Bezerra de Araujo Filho, Cleyton Zanardo DE Oliveira, Ana Paula Ribeiro Paiotti, Nora Manoukian Forones

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Arquivos de gastroenterologia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

5 authors.

Gabriel Caio DE SouzaUniversidade Federal de São Paulo, Escola Paulista de Medicina, Departamento de Medicina, Programa de Pós-Graduação em Medicina Translacional, São Paulo, SP, Brasil.ORCID http://orcid.org/0000-0003-1479-9856
Humberto Bezerra de Araujo FilhoUniversidade Federal de São Paulo, Escola Paulista de Medicina, Departamento de Medicina, Disciplina de Gastroenterologia Pediátrica, São Paulo, SP, Brasil.ORCID http://orcid.org/0000-0001-6438-0995
Cleyton Zanardo DE OliveiraEnsino e Pesquisa, BP - A Beneficência Portuguesa de São Paulo, São Paulo, SP, Brasil.ORCID http://orcid.org/0000-0002-5611-7668
Ana Paula Ribeiro PaiottiUniversidade Federal de São Paulo, Escola Paulista de Medicina, Departamento de Medicina, Setor de Oncologia, Disciplina de Gastroenterologia, São Paulo, SP, Brasil.ORCID http://orcid.org/0000-0002-2349-4686
Nora Manoukian ForonesUniversidade Federal de São Paulo, Escola Paulista de Medicina, Departamento de Medicina, Setor de Oncologia, Disciplina de Gastroenterologia, São Paulo, SP, Brasil.ORCID http://orcid.org/0000-0001-9414-0343

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemotherapy-induced diarrhea is a common and distressing side effect experienced by patients undergoing cancer treatment, particularly those with gastrointestinal cancer. It can lead to significant health complications, including dehydration, electrolyte imbalances, and treatment interruptions. Recent studies have shown that the gut microbiome plays an important role in the development and severity of chemotherapy-induced diarrhea. Modulating the gut microbiome with probiotics has emerged as a potential strategy for preventing and managing chemotherapy-induced diarrhea.

objectiveIn this study we aimed to evaluate the efficacy of one probiotic containing a mixture of several strains of Lactobacillus and Bifidobacterium species in prevention of chemotherapy induced diarrhea among patients with gastrointestinal cancer.

methodsBetween April 2022 and June 2024, a total of 28 patients diagnosed with gastrointestinal cancer who were intended to receive chemotherapy based on fluoropyrimidine, oxaliplatin, and/or irinotecan were randomized in a ratio 1:1 to receive either a placebo or 20 billion colony-forming units (CFU) of a mixture containing five viable strains including 335 mg of Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37TM, Bifidobacterium lactis Bi-04TM, Bifidobacterium lactis Bi-07TM, and Bifidobacterium bifidum Bb-02TM. Patients were instructed to take the product orally once daily for 90 days and to record their bowel habits in a diary using the Bristol stool scale.

resultsThe use of probiotics, compared to placebo, did not result in reduction of grade 2/3 diarrhea episodes (placebo arm 55.56% vs probiotic arm 44.44%; P=1). Likewise, no statistically significant difference was observed in the overall incidence of diarrhea between the two groups (71.43% vs 64.29%; P=1). The median number of diarrhea episodes during the 90-day follow-up tended to be lower in the probiotic group (eight episodes) compared to the placebo group (9 episodes) (P=0.639) Subgroup analyses failed to identify any specific patient characteristics that associated any benefit from the probiotic use, regardless of diarrhea grade. Also, no infections related to the probiotic strains administered in this study were detected.

conclusionProbiotic in comparison to a 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.

Indexed as

Antineoplastic AgentsDiarrheaGastrointestinal NeoplasmsProbioticsAdultAgedBifidobacteriumDouble-Blind MethodFemaleGastrointestinal MicrobiomeHumansLactobacillusMaleMiddle AgedTreatment OutcomeAntineoplastic Agents

Identifiers

PMID41379184
PMCPMC12683943

What OpenQuestion holds

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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.