Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy

Not Applicable

Not yet recruiting

• Conditions: Pancreatic Cancer, Resected; Diarrhea

• Registration Number: NCT06960122
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study Start: 2025-05-01
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diarrhea HART Score	Assessed every two cycles up to 24 weeks (each cycle is 21 days)	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.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale (GSRS)	Assessed every two cycles up to 24 weeks (each cycle is 21 days)	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.
Quality of Life (QoL) assessment	Assessed every two cycles up to 24 weeks (each cycle is 21 days)	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.
Chemotherapy cycle delay rate	Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Colonization status of intestinal beneficial flora	At baseline, completion of 4 intervention cycles, and completion of 8 intervention cycles (each cycle is 21 days)	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.

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang; 🇨🇳 Hangzhou, Zhejiang, China