Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

Phase 1

• Conditions: Acute Pancreatitis; Fecal Microbiota Transplantation; Infectious Complications; Bacterial Translocation
• Interventions: Drug: The traditional treatment; Procedure: Fecal Microbiota Transplantation

• Registration Number: NCT02318147
• Lead Sponsor: The First Affiliated Hospital of Nanchang University

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.

Study Timeline

• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-17
• Study Start: 2016-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The traditional treatment	The traditional treatment	The traditional treatment of SAP according to the associated guidelines
Fecal Microbiota Transplantation	Fecal Microbiota Transplantation	FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP
Fecal Microbiota Transplantation	The traditional treatment	FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP

Primary Outcome Measures

Name	Time	Method
The control of infectious complications	From admission to discharge	The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value.

Secondary Outcome Measures

Name	Time	Method
C-reactive protein（CRP）level	1day before intervention，7days and 14days after intervention	C-reactive protein (CRP) is a inflammatory prognostic marker
Procalcitionin（PCT）level	1day before intervention，7days and 14days after intervention	Procalcitionin（PCT）level is a inflammatory prognostic marker
Length of Intensive care time and hospital stay	From admission to discharge	The time of stay in the intensive care unit and hospital
Mortality	From admission to discharge	The incidence of death during the time frame

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China