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2025-05-01
2028-12-31
2028-12-31
10
NCT06960122
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
INTERVENTIONAL
Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-04-10 | N/A | 2025-04-28 |
2025-04-28 | N/A | 2025-05-07 |
2025-05-07 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Fecal microbiota transplantation One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy. | PROCEDURE: Fecal Microbiota Transplant (FMT)
|
| ACTIVE_COMPARATOR: Control Standard Therapy Alone | OTHER: Standard Therapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diarrhea HART Score | The Hart Diarrhea Scoring Scale assigns scores to nine categories. The total score is the sum of scores from each bowel movement on the same day, with each movement evaluated using this scale. A cumulative score of ≥12 points within 24 hours is classified as diarrhea. | Assessed every two cycles up to 24 weeks (each cycle is 21 days) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Rating Scale (GSRS) | The total score of the GSRS (Gastrointestinal Symptom Rating Scale) ranges from 0 to 78 points, with higher scores indicating more severe gastrointestinal symptoms in patients. | Assessed every two cycles up to 24 weeks (each cycle is 21 days) |
| Quality of Life (QoL) assessment | The maximum score is 60. A score of less than 20 indicates an extremely poor quality of life; 21-30, poor; 31-40, fair; 41-50, relatively good; and 51-60, good. | Assessed every two cycles up to 24 weeks (each cycle is 21 days) |
| Chemotherapy cycle delay rate | Assessed every two cycles up to 24 weeks (each cycle is 21 days) | |
| Colonization status of intestinal beneficial flora | Stool samples were collected from patients at three time points: baseline, after 4 cycles of intervention, and after 8 cycles of intervention, for 16S rDNA sequencing. | At baseline, completion of 4 intervention cycles, and completion of 8 intervention cycles (each cycle is 21 days) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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