Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis (NCT07153809) | Clinical Trial Compass
RecruitingNot Applicable
Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
China80 participantsStarted 2024-10-12
Plain-language 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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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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 be recovered within 48 hours
* Stage of the disease: Approximately 2 weeks after onset (non acute phase), accompanied by accumulation of pancreatic fluid volume, and significant improvement in CTSI score compared to before (grade II)
* Nutritional support: Enteral nutrition tube has been left in place Feasibility of transplantation: 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 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 in the heart, lungs, liver, kidneys, or blood system Malignant tumor: Suffering from incurable 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 ā¦
What they're measuring
1
Pancreatic infectious complications
Timeframe: through study completion, an average of 1 year