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Fecal Microbiota Transplantation for Pancreatitis

NCT02318134 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-14

Study results available
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Summary

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.

Conditions

  • Acute Pancreatitis
  • Intestinal Bacteria Flora Disturbance
  • Intestinal Dysfunction
  • Fecal Microbiota Transplantation

Interventions

PROCEDURE

Fecal Microbiota Transplantation

FMT via a nasoduodenal tube with fresh bacteria from healthy donor

DRUG

normal saline

Normal saline via a nasoduodenal tube.

Sponsors & Collaborators

  • The First Affiliated Hospital of Nanchang University

    lead OTHER

Principal Investigators

  • Nonghua Lv, MD · the Frist Affiliated Hospital of Nanchang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-18
Primary Completion
2019-04-17
Completion
2019-12-18

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02318134 on ClinicalTrials.gov