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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
FMT
Procedure/SurgeryFMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
Placebo
Procedure/SurgeryPhysiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: FMTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
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
Time frame
through study completion, an average of 1 year2
Changes in gut microbiome community
The average change in bacterial species relative to baseline compared to one week after fecal microbiota transplantation (FMT).
Time frame
Up to 1 week3
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:%
Time frame
Up to 1 weeks4
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.
Time frame
Up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov