NCT06960122Not yet recruiting
Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy
Source: ClinicalTrials.gov · Last updated 7 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 resectable or resectable stage, and surgical resection remains the only curative option. However, total pancreatectomy (TP) often leads to severe diarrhea (incidence rate: 43.5%) due to exocrine insufficiency, and current pancreatic enzyme replacement therapy shows limited efficacy in some patients. Recent studies highlight the critical role of gut microbiota in pancreatic cancer progression and postoperative recovery. Patients with pancreatic ductal adenocarcinoma (PDAC) exhibit a 1000-fold increase in intrapancreatic bacterial load compared to normal tissues, with significantly elevated Bacteroides abundance and reduced Firmicutes and Proteobacteria in fecal samples. Postoperative dysbiosis is linked to complications; for example, diarrhea after cholecystectomy is dominated by Proteobacteria, suggesting that microbial imbalance may underlie diarrhea following TP. To address this, the study proposes fecal microbiota transplantation (FMT) via oral capsules. FMT has proven effective in treating recurrent Clostridium difficile infection by restoring healthy microbiota. This research will systematically evaluate the efficacy and safety of FMT in alleviating post-TP diarrhea through clinical indicators and 16S rDNA sequencing, offering novel insights into postoperative management of pancreatic cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 10 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Pancreatic cancer
- NCT number
- NCT06960122
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 May 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Gastrointestinal perforation and/or fistulas.
- Other conditions deemed ineligible by the investigator.
Other
- Pregnancy or lactation, or women of childbearing potential refusing contraceptive measures during the 15-week observation period.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.