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NCT Number: NCT06960122

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.

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Key information

Conditions

Pancreatic Cancer, Resected Diarrhea Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, China

Location contact

Wen Cai

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Fecal microbiota transplant (FMT)

Procedure

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

Standard therapy

Other

Standard Therapy Alone

Primary outcomes

  1. Diarrhea HART Score

    Time frame: 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 outcomes

  1. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 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.

  2. Quality of Life (QoL) assessment

    Time frame: 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.

  3. Chemotherapy cycle delay rate

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

  4. Colonization status of intestinal beneficial flora

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Acronym: FMT-TP

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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