Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChanghai Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- FMT
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov