Fecal Microbiota Transplantation for Pancreatitis (FMTP)

March 19, 2021 updated by: Lingyu Luo, The First Affiliated Hospital of Nanchang University

Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction

The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host immune system.After the onset of acute pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and endotoxin translocation, which may cause infectious complications which are major causes of death in SAP patients.Recently,FMT was shown its efficacy in the treatment of gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the mechanism by which FMT results in cure of diseases has been poorly understood.This study aims to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier dysfunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus stabilizing intestinal barrier dysfunction,minimizing bacterial translocation and preventing infectious complications.The investigators will further examine the effect of FMT on inflammatory markers，the predictors of Intestinal barrier injury and the incidence of infectious complications.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • 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 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 within <=2 weeks
  3. complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.

Exclusion Criteria:

  1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula
  2. Pregnancy and lactation women
  3. Not signed the informed consent
  4. Diabetes and autoimmune diseases
  5. Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.

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: FMT group
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
Procedure: Fecal Microbiota Transplantation
FMT via a nasoduodenal tube with fresh bacteria from healthy donor
Other Names:
  • Fecal Transplantation
  • Fecal Microbiota Therapy
Placebo Comparator: Control group
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
Drug: normal saline
Normal saline via a nasoduodenal tube.
Other Names:
  • normal saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Gastrointestinal Failure Score Equal 0
Time Frame: one week after intervention
The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. Gastrointestinal failure score is a comprehensive score for assessing gastrointestinal function. Gastrointestinal dysfunction score gets o point meaning enteral nutrition> 50% of the required amount and no intra-abdominal hypertension. GIF score range from 0 to 4, and higher scores mean a worse outcome.
one week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Infectious Complications
Time Frame: 120 days
The incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.
120 days
Number of Participants With Organ Failure
Time Frame: 120 days
The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.
120 days
Number of Participants With Interventions or Surgery
Time Frame: 120 days
number of patients who need extra interventions or surgery
120 days
Length of Intensive Care Time and Hospital Stay
Time Frame: 6 months
patients' Length of Intensive care time and hospital stay due to the disease
6 months
Mortality
Time Frame: 120 days
patients who die due to the diseases
120 days
Diamine Oxidase（DAO）
Time Frame: one week after intervention
Plasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100)
one week after intervention
D-lactate
Time Frame: one week after intervention
Plasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)*100).
one week after intervention

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

Helpful Links

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 18, 2017

Primary Completion (Actual)

April 17, 2019

Study Completion (Actual)

December 18, 2019

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)

April 14, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nanchanguniversity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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