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

Probiotics are a group of viable microorganisms including bacteria and yeasts that if consumed in sufficient amounts, may afford health benefits to the host. The major advantage of probiotic administration is its ability to maintain gut microbial homeostasis, reduce pathogenic microorganisms in the GI tract, and restores homeostasis of intestinal microorganisms. Moreover, by modulating microbiota and immune responses, decreasing bacterial translocation, promoting the function of the gut barrier, inducing anti- inflammatory properties, triggering anti-pathogenic activity, and decreasing tumor development and metastasis, probiotics might contribute to the prevention and treatment of GI cancers and lung cancer. Considering the potential roles of Helicobacter pylori (H. pylori) in the initiation of colorectal and gastric cancers, the possible properties of probiotics against GI neoplasm in humans have been investigated in relation to their suppressive effects on H. pylori. The gut microbiota also has proved to in the response and resistance to immunotherapy. By triggering immune activity, probiotics, as functional dietary supplements, may mitigate neoplastic predisposition and development of GI cancers. Clostridium butyricum is a spore-forming bacillus named for its capacity to produce high amounts of butyric acid and is found in soil. Clostridium butyricum MIYAIRI 588 strain (MIYA-BM) is widely used as probiotic therapy to improve symptoms related to dysbiosis such as constipation, nonantimicrobial diarrhea, and anti- microbial-associated diarrhea in Japan and China. Clostridium butyricum increases beneficial bacteria, especially lactobacilli and bifidobacteria. Bifidobacterium promotes antitumor immunity and facilitates efficacy of antitumor treatment. The antitumor treatments are differed to three types: immune checkpoint blockade, target therapy and chemotherapy. Thus, investigators hypothesized that probiotic Clostridium butyricum therapy (CBT) may enhance the therapeutic efficacy of anti-tumor therapy through the modulation of gut microbiota. Investigators will discuss the different kinds of anti-tumor effect in survival and response after probiotic supplement.

NCT Number	NCT06998823
Lead Sponsor	Chang Gung Memorial Hospital
Conditions	Probiotics, Cancer, Therapy-Related
Enrollment	120 participants
Start Date	2024-03-20
Primary Completion	2025-10-25 (estimated)
Study Completion	2026-11-08 (estimated)
Updated on ClinicalTrials.gov	2025-05-31