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

NCT ID: NCT06998823

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2026-11-08

Brief 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.

Detailed Description

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 colorecta 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.

This is a prospective study. Investigators evaluate 120 participants with advanced malignant tumor consecutively treated with anti-tumor therapy in routine clinical practice at New Taipei Municipal Tucheng Hospital and Linkou branch of Chang Gung Memorial Hospital. These 120 participants were equal to separate three groups: immune therapy, target therapy and chemotherapy. Each group will have 30 participants receiving Probiotics and 10 participants without Probiotics. The include criteria is participants agree to probiotics used. The exclude criteria ia participants refuse probiotics used.90 participants will intake 90days Probiotics (Clostridium butyricum). Investigators also collect these participants' 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 .

Conditions

Probiotics; Cancer, Therapy-Related

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: COMBINATION_PRODUCT

Participants will intake 90days Probiotics

Interventions

Probiotics

Participants will intake 90days Probiotics

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. age≧20

2. participants with cancer therapy and agree to sign informed consent

3. Cancer confirmed by clinical or pathological diagnosis

Exclusion Criteria

1. age<20

2. Pregnant or breastfeeding women

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

ChengHaoTsai

Professor Attending Physicians

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chia-Hsun Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Oncology, Chang Gung Memorial Hospital

Locations

New Taipei City TuCheng Hospital

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

HaoTsai Cheng, PhD

Role: CONTACT

hautai@cgmh.org.tw

03-3281200 ext. 8108

Chia-Hsun Hsieh, PhD

Role: CONTACT

wisdom5000@cgmh.org.tw

0975366137

Facility Contacts

Chia-Hsun Hsieh, PhD

Role: primary

wisdom5000@cgmh.org.tw

0975366137

HaoTsai Cheng, PhD

Role: backup

hautai@cgmh.org.tw

0975368062

Other Identifiers

202201539A3

Identifier Type: -

Identifier Source: org_study_id