The Effect of Survival, Response and Microbiota Change in Different Therapy Under Probiotic Supplement (Clostridium Butyricum) in Patients With Malignant Tumors

What this Trial Is About

Researchers are investigating the effects of probiotics, specifically Clostridium butyricum MIYAIRI 588 strain (MIYA-BM), on patients undergoing different types of anti-tumor therapies for advanced malignant tumors. Probiotics may help maintain gut microbial balance, reduce harmful microorganisms, modulate immune responses, and potentially support the prevention and treatment of gastrointestinal and lung cancers. The study aims to explore how probiotic supplements influence survival, response to treatment, and changes in gut microbiota across immune therapy, targeted therapy, and chemotherapy groups. Participants are divided into three treatment groups based on their anti-tumor therapy type: immune therapy, targeted therapy, and chemotherapy. In each group, some participants receive the probiotic supplement for 90 days, while others do not. Stool samples, liver fibrosis evaluations, and blood are collected before probiotics use, during treatment if the condition changes, and after 90 days to assess microbiota changes, liver health, and phenotypic aging. The study is prospective and involves 120 participants, with 90 taking probiotics and 30 not taking them. During the study, participants undergo stool collection for intestinal microbiota analysis, liver fibrosis assessment using Fibroscan, and blood tests for phenotypic age measurement at baseline, during treatment changes, and after probiotic supplementation. Researchers will measure phenoage scores, metagenomic sequencing data, and liver fibrosis scores at the start and after three months. The study monitors treatment responses and survival outcomes related to probiotic use, with participation lasting through the 90-day probiotic intake and treatment period.

The Effect of Survival, Response and Microbiota Change in Different Therapy Under Probiotic Supplement