Fecal Microbiota Transplantation for Pancreatitis (FMTP)

Nanchang University

Status and phase: Completed; Phase 2

Conditions: Intestinal Dysfunction; Intestinal Bacteria Flora Disturbance; Acute Pancreatitis; Fecal Microbiota Transplantation

Treatments: Procedure: Fecal Microbiota Transplantation; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02318134

Nanchanguniversity

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

FMT group

Experimental group

Description:

In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.

Treatment:

Procedure: Fecal Microbiota Transplantation

Control group

Placebo Comparator group

Description:

In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.

Treatment:

Drug: normal saline