Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis

Naval Military Medical University

Status: Enrolling

Conditions: Acute Pancreatitis; Severe Acute Pancreatitis

Treatments: Procedure: Placebo; Procedure: FMT

Study type: Interventional

Funder types: Other

Identifiers

NCT07153809

CHEC2024-297

Details and patient eligibility

About

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.

Full description

This study is a single center, randomized controlled trial. After the start of the study, 80 patients with acute moderate to severe acute pancreatitis were randomly selected according to inclusion and exclusion criteria and divided into an intervention group (n=40) and a control group (n=40) to explore the safety and efficacy of FMT in preventing late complications of acute moderate to severe acute pancreatitis.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.

Treatment:

Procedure: Placebo

FMT

Experimental group

Description:

FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days. After intestinal preparation (via nasal feeding of inulin or oligofructose 24 hours before FMT), the subjects underwent 5-6 consecutive FMT treatments (injecting 100ml of standard bacterial solution 1/d into the nasojejunal nutrition tube, with a minimum of 2.5 \* 1012 CFU of viable cells per 50mL of bacterial solution). FMT intervention can be performed when the subject's intestinal function is restored and SIRS indicators are significantly relieved compared to before. During the research period, long-term use of probiotics, antibiotics, and other foods and drugs that interfere with and damage gut microbiota is prohibited. Subjects need to be informed in advance before taking any medication. All subjects need to complete relevant examinations before enrollment. Conduct a comprehensive safety and efficacy evaluation during treatment, after treatment, and one week after treatment.

Treatment:

Procedure: FMT