Fecal microbiota transplant for people with moderate to severe acute pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Kong Xiang yu, associate professor
• Email: xiangyukong185@hotmail.com
• Phone: 13564644397

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Local complications of acute pancreatitis and postoperative pancreatic fistula: what happens in real life

  This multicenter registry tests how local pancreatic complications are managed in routine care and what outcomes look like over 180 days for adults.

  Recruiting at 12 sites Tokyo University · Ōtsu, Shiga and 11 other locations · NCT07862088

• SGC001 is being tested to help predicted severe acute pancreatitis

  Researchers are testing SGC001 vs placebo in adults with predicted severe acute pancreatitis to see if it is safe and tolerable and to get a sense of any early effects.

  Recruiting Phase 2 Beijing Sungen Biomedical Technology Co., Ltd · Chengdu and 14 other locations · NCT07803965

• Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis

  This trial will test whether giving healthy donor gut bacteria (fecal microbiota transplantation) through a feeding tube in the late phase of moderately severe or severe acute pancreatitis can prevent infectious complications.

  Recruiting Changhai Hospital · Fuzhou, Fujian and 11 other locations · NCT07464392

• How often splanchnic vein clots occur in acute pancreatitis and whether they relate to disease severity

  This project will see if people with acute pancreatitis develop blood clots in the splenic, portal, or superior mesenteric veins and whether those clots are linked to more severe illness.

  Recruiting Asian Institute of Gastroenterology, India · Hyderabad, Telangana · NCT07322978

• Blood markers to detect infected pancreatic necrosis

  We will test whether specific blood markers can help predict or diagnose infected pancreatic necrosis in adults with necrotizing pancreatitis.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT06899087

• Using bowel sounds to predict severe acute pancreatitis

  This study is testing if monitoring bowel sounds can help doctors predict which patients with acute pancreatitis might develop severe complications.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06867120

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.