Phase 2
N=60
Fecal Microbiota Transplantation for Pancreatitis
Acute Pancreatitis · Intestinal Bacteria Flora Disturbance · Intestinal Dysfunction · Fecal Microbiota Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT02318134 ↗Enrolled (actual)
60
Serious AEs
80.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Gastrointestinal Failure Score Equal 0 — 12; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fecal Microbiota Transplantation (Procedure); normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The First Affiliated Hospital of Nanchang University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Gastrointestinal Failure Score Equal 0 |
12; 14 | — |
| SECONDARY Number of Participants With Infectious Complications |
15; 16; 4; 8; 10; 9 | — |
| SECONDARY Number of Participants With Organ Failure |
24; 23; 24; 21; 3; 5 | — |
| SECONDARY Number of Participants With Interventions or Surgery |
10; 11; 6; 7; 1; 1 | — |
| SECONDARY Length of Intensive Care Time and Hospital Stay |
9; 11; 18.5; 23 | — |
| SECONDARY Mortality |
3; 4 | — |
| SECONDARY Diamine Oxidase（DAO） |
-0.21; -0.05 | — |
| SECONDARY D-lactate |
0.37; -0.28 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02318134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.