Trials / Completed
CompletedNCT02318134
Fecal Microbiota Transplantation for Pancreatitis
Fecal Microbiota Transplantation in SAP（Severe Acute Pancreatitis）Patients With Intestinal Barrier Dysfunction
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- The First Affiliated Hospital of Nanchang University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Acute Pancreatitis
- Intestinal Bacteria Flora Disturbance
- Intestinal Dysfunction
- Fecal Microbiota Transplantation
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Fecal Microbiota Transplantation | FMT via a nasoduodenal tube with fresh bacteria from healthy donor |
| DRUG | normal saline | Normal saline via a nasoduodenal tube. |
Timeline
- Start date
- 2017-11-18
- Primary completion
- 2019-04-17
- Completion
- 2019-12-18
- First posted
- 2014-12-17
- Last updated
- 2021-04-14
- Results posted
- 2021-04-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02318134. Inclusion in this directory is not an endorsement.