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Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy

NCT06960122 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-07

No results posted yet for this study

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 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.

Conditions

Interventions

PROCEDURE

Fecal Microbiota Transplant (FMT)

One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy.

OTHER

Standard Therapy

Standard Therapy Alone

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Wen Cai · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960122 on ClinicalTrials.gov