The Study on the Efficacy and Safety of Lactobacillus Johnsonii in Combination with CapeOX and Pembrolizumab for the Treatment of MSS/pMMR Metastatic Colorectal Cancer.

NANot yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

March 1, 2026

Study Completion Date

June 1, 2026

Conditions
Metastatic Colorectal Cancer (CRC)
Interventions
DIETARY_SUPPLEMENT

Lactobacillus johnsonii

It is previously reported Lactobacillus johnsonii #CGMCC29884 in Cell. Animal studies showed it combined with Clostridium sporogenes to produce indolepropionic acid, modulating CD8+ T cell immune quiescence in the tumor microenvironment and sensitizing immunotherapy in CRC, breast cancer, and melanoma. Mager et al. found Lactobacillus johnsonii enhanced CTLA-4 mAb antitumor effects in CRC mouse models. Studies showed it's a typical probiotic widely distributed in various hosts' guts and has long been applied in food and feed industries. Preclinical studies indicated it improved memory through the gut-brain axis, had anti-inflammatory and antibacterial effects, and regulated metabolic diseases. Randomized trials found it effectively inhibited Helicobacter pylori colonization without obvious adverse reactions, suggesting it's a potentially safe and effective treatment.

OTHER

Placebo

Placebo

All Listed Sponsors
collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Zhejiang Cancer Hospital

OTHER

lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER