How probiotics affect survival, treatment response, and gut microbiota during cancer therapy
The Effect of Survival, Response and Microbiota Change in Different Therapy Under Probiotic Supplement (Clostridium Butyricum) in Patient With Malignant Tumor
This test will see if taking a probiotic supplement during cancer treatment helps adults with cancer live longer, respond better to therapy, or have healthier gut bacteria.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT06998823 on ClinicalTrials.gov |
What this trial studies
This interventional study gives an oral probiotic supplement to adults with confirmed cancer who are receiving cancer therapy and follows them over time. Researchers will track clinical outcomes such as survival and treatment response while measuring changes in the gut microbiota. Stool and clinical data will be collected at scheduled visits to compare microbiome composition and clinical outcomes before and after probiotic use. Participants younger than 20 and pregnant or breastfeeding people are excluded from participation.
Who should consider this trial
Good fit: Adults aged 20 or older with a confirmed cancer diagnosis who are undergoing cancer therapy and can give informed consent are ideal candidates.
Not a fit: People under age 20, and pregnant or breastfeeding individuals are excluded and would not qualify to receive potential benefit from this protocol.
Why it matters
Potential benefit: If successful, the probiotic could improve treatment response, support gut microbial balance, and potentially improve survival or reduce therapy-related complications.
How similar studies have performed: Prior small clinical and preclinical studies suggest probiotics can modify the gut microbiome and influence treatment responses, but strong evidence for improved survival in cancer patients is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Taipei City
- New Taipei City TuCheng Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chia-Hsun Hsieh, PhD — Division of Oncology, Chang Gung Memorial Hospital
- Study coordinator: HaoTsai Cheng, PhD
- Email: hautai@cgmh.org.tw
- Phone: 03-3281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.