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RECRUITING
NCT06998823
NA

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

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: The Effect of Survival, Response and Microbiota Change in Different Therapy Under Probiotic Supplement (Clostridium Butyricum) in Patient With Malignant Tumor

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-03-20

Completion Date

2026-11-08

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Probiotics

Participants will intake 90days Probiotics

Locations (1)

New Taipei City TuCheng Hospital

New Taipei City, Taiwan