Actively Recruiting
Study of Fecal Microbiota Transplantation to Reduce Chemotherapy Side Effects in Adults with Advanced Gastrointestinal Cancers
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-06
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether fecal microbiota transplantation FMT can help treat gastrointestinal symptoms caused by chemotherapy or targeted therapy in patients with gastrointestinal cancers. This Phase 1 trial aims to evaluate the effect of FMT on the gastrointestinal tract in these patients, focusing on those with advanced gastrointestinal tumors. The goal is to understand how FMT might reduce side effects linked to cancer treatment. Participants are randomly assigned to one of two groups. The control group continues their usual chemotherapy or targeted therapy cycles every three weeks for five cycles, with treatment effectiveness assessed after every two cycles. The experimental group receives FMT starting from the fourth treatment cycle, with capsules containing donor gut bacteria given orally within three days before chemotherapy during the fourth, sixth, and eighth cycles. Each FMT dose includes about 40 grams of bacteria encapsulated into 120 capsules, taken over a short period during each treatment cycle. Throughout the study, patients undergo regular assessments to track gastrointestinal symptoms and gut microbiota changes. Researchers monitor the incidence and improvement of gastrointestinal side effects at 4 and 8 weeks after FMT. They also analyze gut microbiota diversity and its correlation with symptom improvement. Participants are followed during treatment cycles and for a post-treatment period to evaluate these outcomes, with safety and organ function closely observed.
CONDITIONS
Brief Title
A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Estimated survival time of at least 3 months
- Confirmed diagnosis of gastrointestinal tumors (e.g., esophageal, gastric, colon, rectal cancer) by pathology
- Cancer at TNM Stage IV
- Completed PD-1 or PD-L1 testing
- Planned to receive the 4th cycle of chemotherapy or targeted therapy
- Experienced gastrointestinal side effects (diarrhea, constipation, vomiting, nausea, etc.) during the first 3 cycles of chemotherapy or targeted therapy
- Able and willing to sign informed consent and complete follow-up
- Eastern Cooperative Oncology Group (ECOG) Performance Status score between 1 and 3
- Use of oral or intravenous broad-spectrum antibiotics with caution within 3 days
- Able to swallow capsules without chewing
- Laboratory tests during screening show sufficient organ function
You will not qualify if you...
- Major organ dysfunction or failure, including heart, kidney, or liver problems
- Uncontrolled or severe infections
- History of psychotropic substance abuse, alcoholism, or drug abuse
- Severe infections complicated by septicemia or sepsis
- History of severe allergic reactions or allergy to components of the bacteria capsules
- Active viral infections
- Positive pregnancy test, breastfeeding, or refusal to use contraception during the 15-week observation period
- Gastrointestinal perforation or fistula
- Any other condition deemed unsuitable by the investigator
Research Team
D
Da Wang
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here