Randomized trial assessing impact of probiotic supplementation on gut microbiome and clinical outcome from targeted therapy in metastatic renal cell carcinoma

source extracted confidence: high 2026-04-09
#adult #aged #aged-80-and-over #antineoplastic-agents #bacteria

Randomized trial assessing impact of probiotic supplementation on gut microbiome and clinical outcome from targeted therapy in metastatic renal cell carcinoma

Dizman et al., 2021 | Cancer Med | Rct

Citation

Dizman Nazli, Hsu JoAnn, ... Pal Sumanta K. Randomized trial assessing impact of probiotic supplementation on gut microbiome and clinical outcome from targeted therapy in metastatic renal cell carcinoma. Cancer Med. 2021-Jan;10(1):79-86. doi:10.1002/cam4.3569

Abstract

Studies suggest a link between the gut microbiome and metastatic renal cell carcinoma (mRCC) outcomes, including evidence that mRCC patients possess a lower abundance of Bifidobacterium spp. compared to healthy adults. We sought to assess if a Bifidobacterium-containing yogurt product could modulate the gut microbiome and clinical outcome from vascular endothelial growth factor-tyrosine kinase inhibitors (VEGF-TKIs). mRCC patients initiating VEGF-TKIs, regardless of the line of therapy, were randomized to probiotic-supplemented (two 4 oz. servings of the probiotic yogurt product daily) or probiotic-restricted arms. Stool samples were collected prior to therapy and at weeks 2, 3, 4, and 12. Microbiome composition was assessed using whole-metagenome sequencing. A total of 20 patients were randomized. Bifidobacterium animalis, the active ingredient of the probiotic supplement, reached detectable levels in all patients in the probiotic-supplemented arm versus two patients in the probiotic-restricted arm. Clinical benefit rate was similar in probiotic-supplemented versus probiotic-restricted arms (70% vs. 80%, p = 0.606). Linear discriminant analysis (LDA) effect size analysis of MetaPhIAn2 abundance data predicted 25 enriched species demonstrating an LDA score >3 in either clinical benefit or no clinical benefit. In patients with clinical benefit (vs. no clinical benefit), Barnesiella intestinihominis and Akkermansia muciniphila were significantly more abundant (p = 7.4 × 10-6 and p = 5.6 × 10-3 , respectively). This is the first prospective randomized study demonstrating modulation of the gut microbiome with a probiotic in mRCC. Probiotic supplementation successfully increased the Bifidobacterium spp. levels. Analysis of longitudinal stool specimens identified an association between B. intestinihominis, A. muciniphila, and clinical benefit with therapy. Trial Registration: NCT02944617.

Key Findings

Trial Registration: NCT02944617.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population clinical benefit
Sample Size 20
Age Range See abstract
Condition See abstract

MeSH Terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents
  • Bacteria
  • California
  • Carcinoma, Renal Cell
  • Feces
  • Female
  • Gastrointestinal Microbiome
  • Host-Pathogen Interactions
  • Humans
  • Intestines
  • Kidney Neoplasms
  • Male
  • Middle Aged
  • Molecular Targeted Therapy
  • Probiotics
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • Yogurt

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
  • Vertical: probiotics-gut

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09