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Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

N

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

Trial contacts and locations

1

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Central trial contact

Yin Zhu, MD; Lingyu Luo, MD

Data sourced from clinicaltrials.gov

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