Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC)

October 16, 2017 updated by: Lingyu Luo, The First Affiliated Hospital of Nanchang University

Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Infectious Complications

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Microbiota Transplantation
FMT by retention enema with fresh bacteria from healthy donor，At the same time give patients the traditional treatment of SAP
Procedure: Fecal Microbiota Transplantation
FMT by retention enema with fresh bacteria from healthy donor
Other Names:
  • Fecal Transplantation
  • Fecal Microbiota Therapy
Drug: The traditional treatment
the traditional treatments according to associated guidelines
Other Names:
  • Conventional drugs according to the guideline
Other: The traditional treatment
The traditional treatment of SAP according to the associated guidelines
Drug: The traditional treatment
the traditional treatments according to associated guidelines
Other Names:
  • Conventional drugs according to the guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The control of infectious complications
Time Frame: From admission to discharge
The temperature recovered to normal for 3 days. The inflammatory cytokines decreased to the normal value.
From admission to discharge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Nanchang University

Investigators

  • Study Chair: Nonghua Lv, MD, the Frist Affiliated Hospital of Nanchang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanchanguniversityII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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