Clinical Trials in China / NCT07153809
Recruiting
Not applicable
Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
NCT07153809 · tracked via the Priya Life Science China tracker
Condition(s) studied
Acute PancreatitisSevere Acute Pancreatitis
Investigational drug(s) / intervention(s)
FMTPlacebo
FMT: FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
Placebo: Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
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
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 50% of calorie requirements due to severe diarrhea, fibrotic intestinal stenosis, severe gastrointestinal edema, high flow intestinal fistula, etc
* Systemic infection: meets the diagnostic criteria for systemic inflammatory response syndrome (SIRS)
* Antibiotic dependence: broad-spectrum antibiotic intervention is required for combined extraintestinal organ infections
* Immunodeficiency: Congenital or acquired immunodeficiency
* Mental illness: severe mental disorders
Primary outcome measure(s)
- Pancreatic infectious complications — through study completion, an average of 1 year
Infectious pancreatic necrosis, sepsis, and pancreatic fistula. Infectious pancreatic necrosis: (1) Imaging suggests the formation of gas at the site of necrosis aggregation; (2) Gram staining or culture positivity of necrotic specimens obtained through percutaneous fine needle aspiration (FNAC); (3) Clinically suspected infection symptoms. However, due to the high false positive rate, routine FNAC examination is not recommended. Sepsis: (1) Two blood cultures (or bone marrow cultures) are positive for the same pathogen. (2) Systemic inflammatory response syndrome (SIRS) occurs. Pancreatic fistula: (1) History of acute necrotizing pancreatitis attacks; (2) Imaging supports the diagnosis of pancreatic fistula. Measurement: Yes/No (incidence rate)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Changhai Hospital | Shanghai | Shanghai Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07153809 on ClinicalTrials.gov ↗ ← All trials in China