Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy (FMT-TP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diarrhea; Pancreatic Cancer, Resected
• Intervention / Treatment: Other: Standard Therapy; Procedure: Fecal Microbiota Transplant (FMT)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang
      • Contact: Wen Cai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard Therapy Alone	Other: Standard Therapy; Standard Therapy Alone
Experimental: Fecal microbiota transplantation; One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy.	Procedure: Fecal Microbiota Transplant (FMT); One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Wen Cai, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: 2025-0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No