Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FMT, Placebo.
- Who it may be relevant to
- Registry conditions: Acute Pancreatitis, Severe Acute Pancreatitis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis
Overview
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.
Detailed 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.
Interventions
- Procedure FMT
FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days. - Procedure Placebo
Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
Primary outcome measures
- Pancreatic infectious complications [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (7)
- Change in CTSI score [Time frame: through study completion, an average of 1 year]
- Changes in gut microbiome community [Time frame: Up to 1 week]
- Gastrointestinal mucosal barrier index [Time frame: Up to 1 weeks]
- Markers of inflammatory conditions [Time frame: Up to 3 months]
- Inflammatory markers [Time frame: Up to 3 months]
- Inflammatory markers [Time frame: Up to 3 months]
- Inflammatory markers [Time frame: Up to 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Changhai Hospital — Shanghai
- Changhai Hospital — Shanghai
Identifiers
NCT: NCT07153809 · CHEC2024-297