Clinical trial NCT02318134: Fecal Microbiota Transplantation for Pancreatitis
Official title: Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pancreatitis
Intestinal Bacteria Flora Disturbance
Intestinal Dysfunction
Fecal Microbiota Transplantation
Keywords: Severe acute pancreatitis
Fecal Microbiota Transplantation
Intestinal barrier dysfunction
Intestinal flora
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host immune system.After the onset of acute pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and endotoxin translocation, which may cause infectious complications which are major causes of death in SAP patients.Recently,FMT was shown its efficacy in the treatment of gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the mechanism by which FMT results in cure of diseases has been poorly understood.This study aims to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier dysfunction.

Detailed description: Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus stabilizing intestinal barrier dysfunction,minimizing bacterial translocation and preventing infectious complications.The investigators will further examine the effect of FMT on inflammatory markers，the predictors of Intestinal barrier injury and the incidence of infectious complications.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of acute pancreatitis from the First Affiliated Hospital of Nanchang University according to the Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus
2. Onset of pancreatitis within \<=2 weeks
3. complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.

Exclusion Criteria:

1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula
2. Pregnancy and lactation women
3. Not signed the informed consent
4. Diabetes and autoimmune diseases
5. Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.

Primary outcomes:
measure: Number of Participants With Gastrointestinal Failure Score Equal 0
timeFrame: one week after intervention
Secondary outcomes:
measure: Number of Participants With Infectious Complications
timeFrame: 120 days
measure: Number of Participants With Organ Failure
timeFrame: 120 days
measure: Number of Participants With Interventions or Surgery
timeFrame: 120 days
measure: Length of Intensive Care Time and Hospital Stay
timeFrame: 6 months
measure: Mortality
timeFrame: 120 days
measure: Diamine Oxidase（DAO）
timeFrame: one week after intervention
measure: D-lactate
timeFrame: one week after intervention
Other outcomes:
Locations:
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: the Frist Affiliated Hospital of Nanchang University
name: Nonghua Lv, MD
role: STUDY_CHAIR
References:
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