The effects of a modified Mediterranean diet on gut microbiota and clinical outcomes in patients with metastatic colorectal cancer undergoing first-line chemotherapy with either anti-EGFR or anti-VEGF agent: protocol for a randomized pilot study (Preprint) DOI Creative Commons

Salvatore Artale,

Francesca Filiali,

Elena Beretta

et al.

Published: Feb. 21, 2025

BACKGROUND the gut microbiota is attracting increasing interest as an initiator of colorectal cancer. It has been observed that microbial imbalance in and cancer tissue facilitated by a Western type diet, rich meat, sugars, refined grains, while Mediterranean low saturated fat fibers, promotes eubiosis, results reduced risk developing OBJECTIVE to analyze compare patients with metastatic undergoing first-line chemotherapy +/- biological agent (anti-EGFR or anti-VEGF), receiving either free standard modified diet. METHODS this pilot non-drug, interventional prospective, randomized, controlled, single-center, open-label trial. Patients (n=40) will be randomized 1:1 diet Blood fecal samples collected at baseline control visits, for metagenomic metabolomic analysis. The primary endpoint Firmicutes/Bacteroidetes ratio after completion third cycle (time T1). Secondary endpoints are: a) percentage experiencing gastrointestinal side effects T1; b) grade 3/4 c) changes ratio, overall microbiome composition, metabolome T1, sixth (T2) versus baseline. RESULTS trial received ethics approval on July 24th 2024. By January 2025, 7 participants have recruited. study conclude visit T2 last enrolled patient. Results are expected published October 2028. CONCLUSIONS potential provide critical insights into role modifying microbiota, diminishing chemotherapy-related effects, possibly enhancing therapeutic efficacy Additionally, data may pave way future research immunotherapy, potentially influencing both clinical practice public health strategies. CLINICALTRIAL Clinicaltrial.gov NCT06794931 (https://clinicaltrials.gov/search?term=NCT06794931)

Language: Английский

The effects of a modified Mediterranean diet on gut microbiota and clinical outcomes in patients with metastatic colorectal cancer undergoing first-line chemotherapy with either anti-EGFR or anti-VEGF agent: protocol for a randomized pilot study (Preprint) DOI Creative Commons

Salvatore Artale,

Francesca Filiali,

Elena Beretta

et al.

Published: Feb. 21, 2025

BACKGROUND the gut microbiota is attracting increasing interest as an initiator of colorectal cancer. It has been observed that microbial imbalance in and cancer tissue facilitated by a Western type diet, rich meat, sugars, refined grains, while Mediterranean low saturated fat fibers, promotes eubiosis, results reduced risk developing OBJECTIVE to analyze compare patients with metastatic undergoing first-line chemotherapy +/- biological agent (anti-EGFR or anti-VEGF), receiving either free standard modified diet. METHODS this pilot non-drug, interventional prospective, randomized, controlled, single-center, open-label trial. Patients (n=40) will be randomized 1:1 diet Blood fecal samples collected at baseline control visits, for metagenomic metabolomic analysis. The primary endpoint Firmicutes/Bacteroidetes ratio after completion third cycle (time T1). Secondary endpoints are: a) percentage experiencing gastrointestinal side effects T1; b) grade 3/4 c) changes ratio, overall microbiome composition, metabolome T1, sixth (T2) versus baseline. RESULTS trial received ethics approval on July 24th 2024. By January 2025, 7 participants have recruited. study conclude visit T2 last enrolled patient. Results are expected published October 2028. CONCLUSIONS potential provide critical insights into role modifying microbiota, diminishing chemotherapy-related effects, possibly enhancing therapeutic efficacy Additionally, data may pave way future research immunotherapy, potentially influencing both clinical practice public health strategies. CLINICALTRIAL Clinicaltrial.gov NCT06794931 (https://clinicaltrials.gov/search?term=NCT06794931)

Language: Английский

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