FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis

Официальное название

Fecal Microbiota Transplantation for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis: A Multicenter, Randomized, Double-Blind Clinical Trial

Обзор

The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) works to prevent infections complications in patients in the late phase of moderately severe or severe acute pancreatitis.

Подробное описание

This multicenter, randomized, double-blind, placebo-controlled trial evaluates whether fecal microbiota transplantation (FMT) works to prevent infectious complications in patients in the late phase of moderately severe and severe acute pancreatitis.

Approximately 150 eligible participants will be enrolled across 12 centers in China and randomly assigned to receive either FMT plus standard treatment or placebo plus standard treatment. The intervention is administered via nasojejunal tube once daily for five consecutive days.

The study will assess infection-related outcomes, organ function, nutritional status, gastrointestinal function, gut microbiota changes, need for additional interventions or surgery, mortality, antibiotic use, and healthcare utilization. Exploratory analyses will investigate inflammatory and immune responses, and explore a predictive model based on baseline gut microbiota characteristics and clinical indicators.

All analyses will follow the intention-to-treat principle, aiming to inform better treatment choices and ultimately improve patient outcomes and quality of life.

Вмешательства

• Биопрепарат Fecal Microbiota Transplantation
  Fecal microbiota transplantation (FMT) liquid is a biological intervention consisting of processed and standardized human fecal microbiota from healthy donors, suspended in sterile saline with cryoprotectant.
• Другое Placebo
  Sterile saline (0.9% sodium chloride) solution, packaged identically to FMT liquid with opaque materials to maintain blinding, contains no active components and serves as a placebo control.

Первичные конечные точки

• Incidence of Infectious Complications [Срок оценки: Within 30 days after enrollment]

Вторичные конечные точки (12)

• Incidence of Infectious Complications [Срок оценки: Within 90 days after enrollment]
• Organ Failure [Срок оценки: From enrollment to hospital discharge (up to 90 days)]
• Enteral Nutrition Caloric Intake [Срок оценки: From enrollment to hospital discharge (up to 90 days)]
• NUTRIC Score [Срок оценки: From enrollment to hospital discharge (up to 90 days)]
• Subjective Global Assessment (SGA) [Срок оценки: Baseline, Day 30, Day 60, Day 90]
• Serum Nutritional Protein Markers [Срок оценки: From enrollment to hospital discharge (up to 90 days)]
• Serum Prealbumin [Срок оценки: From enrollment to hospital discharge (up to 90 days)]
• Serum Electrolyte Levels [Срок оценки: From enrollment to hospital discharge (up to 90 days)]
• Body Mass Index (BMI) [Срок оценки: From enrollment to 90-day follow-up]
• Gastrointestinal Symptom Rating Scale (GSRS) [Срок оценки: From enrollment to 90-day follow-up]
• Incidence of Gastrointestinal Adverse Events [Срок оценки: From enrollment to hospital discharge (up to 90 days)]
• Serum Total Bile Acids Level [Срок оценки: From enrollment to hospital discharge (up to 90 days)]

Критерии участия

Критерии включения

• Age between 18 and 75 years
• Diagnosed with moderately severe acute pancreatitis (MSAP) or severe acute pancreatitis (SAP) according to the Revised Atlanta Classification 2012, with CT severity index (CTSI) score > 4
• Disease duration of 15 to 21 days
• Already have a nasojejunal tube in place
• No absolute contraindications to fecal microbiota transplantation
• Voluntarily sign the written informed consent form

Критерии исключения

• Concurrent severe systemic infection
• Concurrent extra-intestinal organ infection requiring intervention with broad-spectrum antibiotics
• Intestinal obstruction, active gastrointestinal bleeding, intestinal perforation, fulminant colitis, or toxic megacolon
• Unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula
• Pre-existing chronic organ dysfunction (heart, lung, liver, kidney, or hematologic system) prior to admission
• Multiple organ dysfunction syndrome (MODS) with a confirmed duration exceeding 2 weeks
• Active malignancy
• Autoimmune disease or immunocompromised status (including solid organ or bone marrow transplantation, AIDS, long-term use of immunosuppressants or hormones)
• Congenital or acquired immunodeficiency
• Pregnancy or breastfeeding
• Severe mental disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 12 центров

• The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine — Фучжоу
• Quanzhou First Hospital, Fujian — Quanzhou
• Guangdong Hospital of Traditional Chinese Medicine — Гуанчжоу
• Guangzhou Medical University Affiliated Panyu Central Hospital — Гуанчжоу
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The Affiliated Qingyuan People's Hospital of Guangzhou Medical University — Qingyuan
• Affiliated Hospital of Guangdong Medical University — Zhanjiang
• Changhai Hospital — Шанхай
• … и ещё 4 центра

Идентификаторы

NCT: NCT07464392 · KTSB20250907011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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