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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days. |
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| FMT | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT | Procedure | FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic infectious complications | 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) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CTSI score | 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 | through study completion, an average of 1 year |
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Inclusion Criteria:
Age: 18-70 years old Diagnosis: Meets the diagnostic criteria for severe acute pancreatitis (SAP)
Abdominal pressure (bladder pressure measurement)<12mmHg â—¦ Existence of spontaneous defecation/exhaust Significant improvement in abdominal distension compared to before
Exclusion Criteria:
Serious complications: combined gastrointestinal bleeding or intestinal fistula
Autoimmune diseases
â—¦ Immunosuppression status (solid organ/bone marrow transplantation history, AIDS, long-term use of immunosuppressants/hormones)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kong Xiang yu, associate professor | Contact | 13564644397 | xiangyukong185@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Procedure | Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days. |
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| Changes in gut microbiome community | The average change in bacterial species relative to baseline compared to one week after fecal microbiota transplantation (FMT). | Up to 1 week |
| Gastrointestinal mucosal barrier index | 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:% | Up to 1 weeks |
| Markers of inflammatory conditions | C-reactive protein (CRP) is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis. | Up to 3 months |
| Inflammatory markers | Procalcitonin (PCT) is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis | Up to 3 months |
| Inflammatory markers | Interleukin-6 (IL-6) is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis | Up to 3 months |
| Inflammatory markers | lactic acid is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis | Up to 3 months |
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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