Status:
NOT_YET_RECRUITING
Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Pancreatic Cancer, Resected
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
By 2030, pancreatic cancer is projected to become the second leading cause of cancer-related deaths, with a 5-year survival rate below 10%. Approximately 20% of patients are diagnosed at a borderline ...
Eligibility Criteria
Inclusion
- Age ≥18 years, regardless of gender.
- Anticipated survival ≥3 months.
- Severe post-total pancreatectomy diarrhea (as per HART score).
- Willing and able to provide written informed consent and complete follow-up assessments.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 1-3.
- No use of oral/intravenous broad-spectrum antibiotics within 3 days prior to enrollment.
- Ability to swallow capsules intact without chewing.
- Adequate organ function confirmed by screening-phase laboratory tests.
Exclusion
- Major organ insufficiency/failure, including but not limited to:
- Cardiac insufficiency or heart failure Renal insufficiency or renal failure Hepatic insufficiency or liver failure
- Uncontrolled or severe infections.
- Documented history of:
- Psychoactive drug abuse Alcoholism Illicit drug use
- Severe infections complicated by sepsis or septicemia.
- History of severe allergic reactions or known hypersensitivity to components of liquid live-bacterial enteric-coated capsules.
- Pregnancy or lactation, or women of childbearing potential refusing contraceptive measures during the 15-week observation period.
- Gastrointestinal perforation and/or fistulas.
- Other conditions deemed ineligible by the investigator.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06960122
Start Date
May 1 2025
End Date
December 31 2028
Last Update
May 7 2025
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang
Hangzhou, Zhejiang, China