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

NCT06998823 | Recruiting

• 1 other identifier: 202201539A3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Probiotics; Cancer, Therapy-Related

Keywords

Probiotics; Immunotherapy; Targeted Therapy; Chemotherapy

Outcome Measures

Primary Outcomes (6)

• phenoage score

  collect 10 mL of peripheral blood, and caculate the phenoage

  baseline

• phenoage score

  collect 10 mL of peripheral blood, and caculate the phenoage

  3 month

• Metagenomic shotgun sequencing

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

  baseline

• Metagenomic shotgun sequencing

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

  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.

  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.

  3 month

Study Arms (2)

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

Combination Product: Probiotics

Interventions

Probiotics COMBINATION_PRODUCT

Participants will intake 90days Probiotics

experimental

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age≧20
• participants with cancer therapy and agree to sign informed consent
• Cancer confirmed by clinical or pathological diagnosis

You may not qualify if:

• age\<20
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

New Taipei City TuCheng Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms, Second Primary

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Chia-Hsun Hsieh, PhD

  Division of Oncology, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HaoTsai Cheng, PhD

CONTACT

03-3281200; hautai@cgmh.org.tw

Chia-Hsun Hsieh, PhD

CONTACT

0975366137; wisdom5000@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Attending Physicians

Model Details: 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).

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: March 20, 2024
• Primary Completion: October 25, 2025
• Study Completion (Estimated): November 8, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)