Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Apr 28, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients who experience severe diarrhea after undergoing a total pancreatectomy, which is a surgery to remove the pancreas, often due to pancreatic cancer. The study aims to see if fecal microbiota transplantation (FMT) can help improve diarrhea symptoms. FMT involves taking healthy bacteria from a donor’s stool and delivering it in capsule form to help restore a balanced gut environment. This treatment has been successful in other conditions, and researchers believe it might also help those suffering from diarrhea after their surgery.

To participate in the trial, individuals must be at least 18 years old and have experienced severe diarrhea following their surgery. They should also be able to take capsules and have no major organ issues or severe infections. Participants will be monitored throughout the study to assess how well the treatment works and its safety. This trial is not yet recruiting participants, but it represents a promising step towards improving the quality of life for patients facing challenges after pancreatic surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years, regardless of gender.
• • 2. Anticipated survival ≥3 months.
• • 3. Severe post-total pancreatectomy diarrhea (as per HART score).
• • 4. Willing and able to provide written informed consent and complete follow-up assessments.
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 1-3.
• • 6. No use of oral/intravenous broad-spectrum antibiotics within 3 days prior to enrollment.
• • 7. Ability to swallow capsules intact without chewing.
• • 8. Adequate organ function confirmed by screening-phase laboratory tests.
• Exclusion Criteria:
• 1. Major organ insufficiency/failure, including but not limited to:
• • Cardiac insufficiency or heart failure Renal insufficiency or renal failure Hepatic insufficiency or liver failure
• • 2. Uncontrolled or severe infections.
• 3. Documented history of:
• • Psychoactive drug abuse Alcoholism Illicit drug use
• • 4. Severe infections complicated by sepsis or septicemia.
• • 5. History of severe allergic reactions or known hypersensitivity to components of liquid live-bacterial enteric-coated capsules.
• • 6. Pregnancy or lactation, or women of childbearing potential refusing contraceptive measures during the 15-week observation period.
• • 7. Gastrointestinal perforation and/or fistulas.
• • 8. Other conditions deemed ineligible by the investigator.