Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT02318134
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fecal Microbiota Transplantation for Pancreatitis
Sponsor:
The First Affiliated Hospital of Nanchang University
Organization:
Study Overview
Official Title:
Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMTP
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: