Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

Nanchang University

Status and phase: Unknown; Phase 1

Conditions: Bacterial Translocation; Infectious Complications; Acute Pancreatitis; Fecal Microbiota Transplantation

Treatments: Drug: The traditional treatment; Procedure: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02318147

NanchanguniversityII

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Fecal Microbiota Transplantation

Experimental group

Description:

FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP

Treatment:

Procedure: Fecal Microbiota Transplantation

Drug: The traditional treatment

The traditional treatment

Other group

Description:

The traditional treatment of SAP according to the associated guidelines

Treatment:

Drug: The traditional treatment