Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled trial enrolling about 150 participants across centers in China who have moderately severe or severe acute pancreatitis in the late phase (15–21 days). Participants are randomized to receive either fecal microbiota transplantation (FMT) or placebo via a nasojejunal tube once daily for five consecutive days in addition to standard care. The study will track infection-related outcomes, organ and gastrointestinal function, nutritional status, antibiotic use, mortality, healthcare utilization, and changes in gut microbiota. Exploratory analyses will examine inflammatory and immune responses and develop a predictive model using baseline microbiota and clinical indicators, with all analyses on an intention-to-treat basis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
  Fuzhou, Fujian, China Not yet recruiting
• Quanzhou First Hospital, Fujian
  Quanzhou, Fujian, China Not yet recruiting
• Guangdong Hospital of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Not yet recruiting
• Guangzhou Medical University Affiliated Panyu Central Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Xiangyu Kong, MD — The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
• Study coordinator: Xiang yu Kong, MD
• Email: xiangyukong185@hotmail.com
• Phone: 13564644397

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fecal microbiota transplant for people with moderate to severe acute pancreatitis

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• Cryotechnology for removing necrotic pancreatic tissue

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.