Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis

Last updated: August 31, 2025
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Treatment

FMT

Placebo

Clinical Study ID

NCT07153809
CHEC2024-297
  • Ages 18-70
  • All Genders

Study Summary

This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT in patients with moderate to severe acute pancreatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age: 18-70 years old Diagnosis: Meets the diagnostic criteria for severe acute pancreatitis (SAP)

  • Organ function: There may be organ failure and systemic complications that can berecovered within 48 hours

  • Stage of the disease: Approximately 2 weeks after onset (non acute phase),accompanied by accumulation of pancreatic fluid volume, and significant improvementin CTSI score compared to before (grade II)

  • Nutritional support: Enteral nutrition tube has been left in place Feasibility oftransplantation: No absolute contraindications for gut microbiota transplantation

  • Informed Consent: Voluntarily sign a written informed consent form

  • Gastrointestinal status:

Abdominal pressure (bladder pressure measurement)<12mmHg ◦ Existence of spontaneous defecation/exhaust Significant improvement in abdominal distension compared to before

Exclusion

Exclusion Criteria:

Serious complications: combined gastrointestinal bleeding or intestinal fistula

  • Special population: Pregnant or lactating women

  • Informed refusal: Failure to sign informed consent form

  • Basic organ dysfunction: Prior to admission, there were chronic organ dysfunction inthe heart, lungs, liver, kidneys, or blood system Malignant tumor: Suffering fromincurable malignant tumors

  • Immune abnormalities:

Autoimmune diseases

◦ Immunosuppression status (solid organ/bone marrow transplantation history, AIDS, long-term use of immunosuppressants/hormones)

  • Enteral nutrition intolerance: unable to meet 50% of calorie requirements due tosevere diarrhea, fibrotic intestinal stenosis, severe gastrointestinal edema, highflow intestinal fistula, etc

  • Systemic infection: meets the diagnostic criteria for systemic inflammatory responsesyndrome (SIRS)

  • Antibiotic dependence: broad-spectrum antibiotic intervention is required forcombined extraintestinal organ infections

  • Immunodeficiency: Congenital or acquired immunodeficiency

  • Mental illness: severe mental disorders

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: FMT
Phase:
Study Start date:
October 12, 2024
Estimated Completion Date:
December 31, 2026

Study Description

This study is a single center, randomized controlled trial. After the start of the study, 80 patients with acute moderate to severe acute pancreatitis were randomly selected according to inclusion and exclusion criteria and divided into an intervention group (n=40) and a control group (n=40) to explore the safety and efficacy of FMT in preventing late complications of acute moderate to severe acute pancreatitis.

Connect with a study center

  • Changhai Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200433
    China

    Active - Recruiting

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