Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT06998823

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

Led by Chang Gung Memorial Hospital · Updated on 2025-05-31

120

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older
  • Participants receiving cancer therapy and willing to sign informed consent
  • Cancer confirmed by clinical or pathological diagnosis
Not Eligible

You will not qualify if you...

  • Younger than 20 years old
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

New Taipei City TuCheng Hospital

New Taipei City, Taiwan

Actively Recruiting

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Research Team

H

HaoTsai Cheng, PhD

CONTACT

C

Chia-Hsun Hsieh, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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