Clinical trialNo phase (not a drug trial)Not yet recruiting
Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy
- Outcome
- Ongoing
- Phase
- No phase (not a drug trial)
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 1 May 2025
- Expected end
- 31 December 2028
- Enrollment
- 10 participants
- Sites
- 1
- Primary outcomes
- Diarrhea HART Score
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 7 May 2025
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Brief summary public domain (ClinicalTrials.gov)
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.