Acute Pancreatitis, Severe Acute Pancreatitis
Conditions
Brief 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.
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
PROCEDUREFMT
FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
PROCEDUREPlacebo
Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CTSI score | through study completion, an average of 1 year | The CT Severity Score (CTSI) of acute pancreatitis can evaluate the severity of acute pancreatitis, predict the probability of complications such as organ failure in the early stages of the disease, and assess the prognosis of patients Method: Measure CTSI scores during baseline and after FMT treatment |
| Changes in gut microbiome community | Up to 1 week | The average change in bacterial species relative to baseline compared to one week after fecal microbiota transplantation (FMT). |
| Gastrointestinal mucosal barrier index | Up to 1 weeks | Diamine oxidase (DAO): It is a marker enzyme of intestinal mucosal cells. D-Lactic acid: It is a metabolic product of intestinal bacteria. Under normal circumstances, the content in plasma is extremely low. When the intestinal mucosa is damaged, DAO and D-lactate will be released into the blood in large quantities, leading to a significant increase in blood concentration, which is an important indicator for evaluating the structural integrity of the intestinal mucosa. During the treatment process, changes in DAO and D-lactate levels can reflect the progress of intestinal mucosal repair. DAO decline rate Formula: (Baseline Value -7-Day Value)/Baseline Value x 100% Unit:% D-lactic acid decline rate Formula: (Baseline Value -7-Day Value)/Baseline Value x 100% Unit:% |
| Markers of inflammatory conditions | Up to 3 months | C-reactive protein (CRP) is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis. |
| Inflammatory markers | Up to 3 months | Procalcitonin (PCT) is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis |
Countries
China
Contacts
Primary ContactKong Xiang yu, associate professor
Outcome results
None listed