Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07464392
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07464392
Study Brief:
Protocol Section:
NCT07464392