ProbioticsNCT06998823
The Effect of Survival, Response and Microbiota Change in Different Therapy Under Probiotic Supplement
A study testing Probiotics in people with Probiotics and Cancer, Therapy-Related, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Probiotics, Cancer, Therapy-Related
- What is being tested?
- Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2024to 8 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≧20
- participants with cancer therapy and agree to sign informed consent
- Cancer confirmed by clinical or pathological diagnosis
Who cannot join
- age<20
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
New Taipei City TuCheng Hospital
New Taipei City
Chia-Hsun Hsieh, PhD, 0975366137, wisdom5000@cgmh.org.tw
HaoTsai Cheng, PhD, 0975368062, hautai@cgmh.org.tw
About this study
Official title: The Effect of Survival, Response and Microbiota Change in Different Therapy Under Probiotic Supplement (Clostridium Butyricum) in Patient With Malignant Tumor
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 .
- Conditions
- Probiotics, Cancer, Therapy-Related
- Being tested
- Probiotics
- Keywords
- Probiotics, Immunotherapy, Targeted Therapy, Chemotherapy
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsCombination product
Participants will intake 90days Probiotics
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | 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 Receives: Combination Product: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
phenoage score
collect 10 mL of peripheral blood, and caculate the phenoage
Measured: baseline
phenoage score
collect 10 mL of peripheral blood, and caculate the phenoage
Measured: 3 month
Metagenomic shotgun sequencing
Collect stool samples to analyze the types and unique characteristics of microorganisms
Measured: baseline
Metagenomic shotgun sequencing
Collect stool samples to analyze the types and unique characteristics of microorganisms
Measured: 3 month
Liver Fibrosis score
do the liver fibrosis assessment by using fibroscan for evaluating the impact on liver fibrosis after taking Probiotics and caner therapy.
Measured: baseline
Liver Fibrosis score
do the liver fibrosis assessment by using fibroscan for evaluating the impact on liver fibrosis after taking Probiotics and caner therapy.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start20 Mar 2024
- Primary completion25 Oct 2025 (estimated)
- Study completion8 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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. 30 participants don't intake Probiotics. 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChengHaoTsai, Chang Gung Memorial Hospital
- Investigators
- Chia-Hsun Hsieh, PhD, Principal investigator, Division of Oncology, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998823
- Sponsor's protocol ID
- 202201539A3
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Survival, Response and Microbiota Change in Different Therapy Under Probiotic Supplement (Clostridium Butyricum) in Patient With Malignant Tumor
- ClinicalTrials.gov ID
- NCT06998823
- Acronym / sponsor ID
- 202201539A3
- Conditions
- Probiotics, Cancer, Therapy-Related
- Keywords
- Probiotics, Immunotherapy, Targeted Therapy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 8 Nov 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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. 30 participants don't intake Probiotics. 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).
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –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 | Combination Product: ProbioticsParticipants 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age≧20
- participants with cancer therapy and agree to sign informed consent
- Cancer confirmed by clinical or pathological diagnosis
Key exclusion criteria (2 listed)
- age<20
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsParticipants will intake 90days Probiotics | Combination product | experimental |
Primary outcome
phenoage score
Time frame: baseline
collect 10 mL of peripheral blood, and caculate the phenoage
phenoage score
Time frame: 3 month
collect 10 mL of peripheral blood, and caculate the phenoage
Metagenomic shotgun sequencing
Time frame: baseline
Collect stool samples to analyze the types and unique characteristics of microorganisms
Metagenomic shotgun sequencing
Time frame: 3 month
Collect stool samples to analyze the types and unique characteristics of microorganisms
Liver Fibrosis score
Time frame: baseline
do the liver fibrosis assessment by using fibroscan for evaluating the impact on liver fibrosis after taking Probiotics and caner therapy.
Liver Fibrosis score
Time frame: 3 month
do the liver fibrosis assessment by using fibroscan for evaluating the impact on liver fibrosis after taking Probiotics and caner therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
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Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
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Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
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Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chia-Hsun Hsieh, PhD principal investigator
Division of Oncology, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Probiotics and Cancer, Therapy-Related, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HaoTsai Cheng, PhD (03-3281200 ext. 8108, hautai@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phenoage score (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.