Clinical trial NCT02318147: Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)
Official title: Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Infectious Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Pancreatitis
Fecal Microbiota Transplantation
Bacterial Translocation
Infectious Complications
Keywords: Severe acute pancreatitis
Fecal Microbiota Transplantation
Bacterial Translocation
Infectious Complications
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: Infectious complications are responsible for most of deaths in acute pancreatitis.Intestinal barrier dysfunction and increased intestinal permeability was associated with bacterial translocation which is believed to prompted these infections.The purpose of this clinical trail is to observe the potential capability of FMT in reduce the bacterial translocation and alleviate infectious complications by the reconstruction of a gut functional state.

Detailed description: Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus minimizing bacterial translocation and alleviating infectious complications. The investigators will further examine the effect of FMT on the incidence of infectious complications，duration of clinical course and mortality.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of severe 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 more than 2 weeks
3. Intestinal bacterium screening tips gut dysbacteriosis
4. Patients with symptoms of infection, such as fever, abdominal pain or blood culture and pancreatic necrosis drainage culture positive patients.

Exclusion Criteria:

1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula
2. Pregnancy and lactation women
3. Not signed the informed consent

Primary outcomes:
measure: The control of infectious complications
timeFrame: From admission to discharge
Secondary outcomes:
measure: C-reactive protein（CRP）level
timeFrame: 1day before intervention，7days and 14days after intervention
measure: Procalcitionin（PCT）level
timeFrame: 1day before intervention，7days and 14days after intervention
measure: Length of Intensive care time and hospital stay
timeFrame: From admission to discharge
measure: Mortality
timeFrame: From admission to discharge
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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