Fecal microbiota transplant for people with moderate to severe acute pancreatitis

Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis

This trial will test whether a fecal microbiota transplant (FMT) can reduce late complications in adults with moderate to severe acute pancreatitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07153809 on ClinicalTrials.gov

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled trial enrolling 80 adults with moderate to severe acute pancreatitis who are about two weeks from symptom onset and have pancreatic fluid collections. Participants are randomly assigned 1:1 to receive FMT or a placebo, with both groups blinded to allocation. Eligible patients generally have an enteral nutrition tube in place, improved CTSI compared with earlier in the course, and no absolute contraindications to gut microbiota transplantation. The study follows participants for safety and for occurrence of late complications related to pancreatitis.

Who should consider this trial

Good fit: Adults aged 18–70 with moderate to severe acute pancreatitis approximately two weeks after onset, stable or recoverable organ function, enteral nutrition tube in place, and no contraindications to gut microbiota transplantation are ideal candidates.

Not a fit: Patients with active gastrointestinal bleeding, intestinal fistula, pregnancy, or unstable/irreversible organ failure (or those without an enteral access route) are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, FMT could lower rates of infected pancreatic necrosis and other late complications, shorten hospital stays, and reduce the need for invasive interventions.

How similar studies have performed: FMT is an established treatment for recurrent C. difficile and has emerging data in critical illness, but its use specifically to prevent late complications of acute pancreatitis is novel and not yet well established.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Kong Xiang yu, associate professor

Conditions Acute Pancreatitis; Severe Acute Pancreatitis