Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy

NCT06960122 | Not Yet Recruiting

• 1 other identifier: 2025-0303
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer, Resected; Diarrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Gastrointestinal Symptom Rating Scale (GSRS)

  Assessed every two cycles up to 24 weeks (each cycle is 21 days)

• Quality of Life (QoL) assessment

  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

  At baseline, completion of 4 intervention cycles, and completion of 8 intervention cycles (each cycle is 21 days)

Study Arms (2)

Fecal microbiota transplantation

EXPERIMENTAL

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

Procedure: Fecal Microbiota Transplant (FMT)

Control

ACTIVE COMPARATOR

Standard Therapy Alone

Other: Standard Therapy

Interventions

Fecal Microbiota Transplant (FMT) PROCEDURE

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

Fecal microbiota transplantation

Standard Therapy OTHER

Standard Therapy Alone

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, regardless of gender.
• Anticipated survival ≥3 months.
• Severe post-total pancreatectomy diarrhea (as per HART score).
• Willing and able to provide written informed consent and complete follow-up assessments.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 1-3.
• No use of oral/intravenous broad-spectrum antibiotics within 3 days prior to enrollment.
• Ability to swallow capsules intact without chewing.
• Adequate organ function confirmed by screening-phase laboratory tests.

You may not qualify if:

• Major organ insufficiency/failure, including but not limited to:
• Cardiac insufficiency or heart failure Renal insufficiency or renal failure Hepatic insufficiency or liver failure
• Uncontrolled or severe infections.
• Documented history of:
• Psychoactive drug abuse Alcoholism Illicit drug use
• Severe infections complicated by sepsis or septicemia.
• History of severe allergic reactions or known hypersensitivity to components of liquid live-bacterial enteric-coated capsules.
• Pregnancy or lactation, or women of childbearing potential refusing contraceptive measures during the 15-week observation period.
• Gastrointestinal perforation and/or fistulas.
• Other conditions deemed ineligible by the investigator.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Diarrhea

Interventions

Fecal Microbiota Transplantation; Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Wen Cai

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)