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RecruitingNCT06998823Updated May 31, 2025

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

An interventional study of Probiotics in Probiotics and Cancer, Therapy-Related, sponsored by Chang Gung Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2024, registered May 2025).
  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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 .

02

Conditions studied

  • Probiotics
  • Cancer, Therapy-Related

Keywords

  • Probiotics
  • Immunotherapy
  • Targeted Therapy
  • Chemotherapy
03

In context

Neoplasms, Second Primary

246 studies on the registry are indexed under Neoplasms, Second Primary; 47 are open to participants now.

This study's planned enrollment of 120 is above the median of 47 across 172 interventional studies indexed under Neoplasms, Second Primary.

Browse Neoplasms, Second Primary studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 237 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. age\<20
  2. Pregnant or breastfeeding women
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • 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

    Combination Product: Probiotics

Interventions

  • Combination productProbiotics

    Participants will intake 90days Probiotics

06

What researchers measure

Primary outcomes

  1. phenoage score

    collect 10 mL of peripheral blood, and caculate the phenoage

    Time frame: baseline

  2. phenoage score

    collect 10 mL of peripheral blood, and caculate the phenoage

    Time frame: 3 month

  3. Metagenomic shotgun sequencing

    Collect stool samples to analyze the types and unique characteristics of microorganisms

    Time frame: baseline

  4. Metagenomic shotgun sequencing

    Collect stool samples to analyze the types and unique characteristics of microorganisms

    Time frame: 3 month

  5. Liver Fibrosis score

    do the liver fibrosis assessment by using fibroscan for evaluating the impact on liver fibrosis after taking Probiotics and caner therapy.

    Time frame: baseline

  6. Liver Fibrosis score

    do the liver fibrosis assessment by using fibroscan for evaluating the impact on liver fibrosis after taking Probiotics and caner therapy.

    Time frame: 3 month

07

Study locations

1 of 1 sites recruiting
  • New Taipei City TuCheng Hospital
    New Taipei City, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06998823
Responsible party
ChengHaoTsai (Professor Attending Physicians, Chang Gung Memorial Hospital) — Principal investigator
First posted
May 31, 2025
Start date
Mar 20, 2024
Primary completion
Oct 25, 2025 (estimated)
Completion
Nov 8, 2026 (estimated)
Last update
May 31, 2025

Study contacts

HaoTsai Cheng, PhD
Contact
hautai@cgmh.org.tw
03-3281200 ext. 8108
Chia-Hsun Hsieh, PhD
Contact
wisdom5000@cgmh.org.tw
0975366137
Chia-Hsun Hsieh, PhD
principal investigator · Division of Oncology, Chang Gung Memorial Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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