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New treatment option for Acute Pancreatitis
Official title Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
ClinicalTrials.gov ID: NCT07153809
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Nutritional support: Enteral nutrition tube has been left in place Feasibility of transplantation: No absolute contraindications for gut microbiota...
- Informed Consent: Voluntarily sign a written informed consent form
You likely can't join if
- 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...
- Immune abnormalities: Autoimmune diseases ◦ Immunosuppression status (solid organ/bone marrow transplantation history, AIDS, long-term use of...
- Enteral nutrition intolerance: unable to meet 50% of calorie requirements due to severe diarrhea, fibrotic intestinal stenosis, severe...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.