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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• age≧20

• participants with cancer therapy and agree to sign informed consent

• Cancer confirmed by clinical or pathological diagnosis

Locations
Other Locations
Taiwan
New Taipei City TuCheng Hospital
RECRUITING
New Taipei City
Contact Information
Primary
HaoTsai Cheng, PhD
hautai@cgmh.org.tw
03-3281200
Backup
Chia-Hsun Hsieh, PhD
wisdom5000@cgmh.org.tw
0975366137
Time Frame
Start Date: 2024-03-20
Estimated Completion Date: 2026-11-08
Participants
Target number of participants: 120
Treatments
No_intervention: control
Participants don't intake Probiotics (Clostridium butyricum). Investigators also collect these patients twice stool for intestinal microbiota, do the fibroscan evaluting and blood drawing for the pheniage assessment before and after Probiotics: 1st time (before cancer treatment), 2nd time (when there are changes in condition during treatment) and 3rd time (after 90days cancer treatment later).
Experimental: experimental
Participants will intake 90days Probiotics (Clostridium butyricum). Investigators also collect these patients' stool for intestinal microbiota, do the liver fibrosis evaluting and blood drawing for the phenoage assessment before taking probiotics, when there are changes in condition during treatment, and after probiotics
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov