Skip to main content
OpenTrials
Completed

NCT Number: NCT02318134

Fecal Microbiota Transplantation for Pancreatitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Pancreatitis Digestive System Diseases Fecal Microbiota Transplantation Intestinal Bacteria Flora Disturbance Intestinal Dysfunction Pancreatic Diseases Pancreatitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Onset of pancreatitis within <=2 weeks
  • 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

  • SAP complicated by Gastrointestinal bleeding or Intestinal fistula
  • Pregnancy and lactation women
  • Not signed the informed consent
  • Diabetes and autoimmune diseases
  • 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.

Treatment and study plan

Fecal Microbiota Transplantation

Procedure

FMT via a nasoduodenal tube with fresh bacteria from healthy donor

Other names: Fecal Microbiota Therapy, Fecal Transplantation

normal saline

Drug

Normal saline via a nasoduodenal tube.

Other names: normal saline 0.9%

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Number of Participants With Organ Failure

    Time frame: 120 days

    The incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.

  3. Number of Participants With Interventions or Surgery

    Time frame: 120 days

    number of patients who need extra interventions or surgery

  4. 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

  5. Mortality

    Time frame: 120 days

    patients who die due to the diseases

  6. 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)

  7. 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).

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

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

Acronym: FMTP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2014
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.