Immune Response to FMT for C.Difficile
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/25/2019 |
| Start Date: | March 22, 2017 |
| End Date: | March 2021 |
| Contact: | William A. Petri, MD,PhD |
| Email: | wap3g@virginia.edu |
| Phone: | 434-924-5621 |
Role of Eosinophils in Innate Protection From C. Difficile
The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by
identifying how Clostridium difficile toxins inhibit eosinophils that otherwise would protect
the gut from damage. This could lead to new and effective approaches to the treatment or
prevention of Clostridium difficile colitis that act downstream of fecal microbiota
transplants (FMT) or next generation probiotics. Successful fecal transplantation will
restore Interleukin-25, Interleukin-4 and eosinophils to the colon
identifying how Clostridium difficile toxins inhibit eosinophils that otherwise would protect
the gut from damage. This could lead to new and effective approaches to the treatment or
prevention of Clostridium difficile colitis that act downstream of fecal microbiota
transplants (FMT) or next generation probiotics. Successful fecal transplantation will
restore Interleukin-25, Interleukin-4 and eosinophils to the colon
Biopsies will be obtained from random areas of the sigmoid colon in subjects at the time of
fecal transplantation. Follow-up biopsies will be obtained from the sigmoid colon during
convalescence 60 days after fecal transplant for subjects who agree to return for optional 60
day follow-up. Biopsies taken for research purposes at each colonoscopy will be analyzed for:
cytokines and chemokines, gene expression analysis, immunohistochemistry and high dimensional
flow-cytometry.
fecal transplantation. Follow-up biopsies will be obtained from the sigmoid colon during
convalescence 60 days after fecal transplant for subjects who agree to return for optional 60
day follow-up. Biopsies taken for research purposes at each colonoscopy will be analyzed for:
cytokines and chemokines, gene expression analysis, immunohistochemistry and high dimensional
flow-cytometry.
Inclusion Criteria:
- one or more relapse of Clostridium difficile colitis
- eligible for fecal microbiota transplant
Exclusion Criteria:
- Unwilling to have biopsies for research conducted at time of FMT
- Concurrent participation in another clinical trial, except outcome of FMT study
- Clinical contraindication to colonoscopy, FMT, flexible sigmoidoscopy or conscious
sedation
- Pregnancy
- Inability to give informed consent
- Incarceration
- Antibiotics unless discontinued 48 hours prior to FMT
- Celiac disease or any other form of inflammatory bowel disease
- HIV infection
- Neutropenia (<1000 PMNs/µl blood)
- Concurrent participation in another clinical trial, except outcome of FMT study
- Anticoagulants if not able to discontinue 5 days prior to endoscopy and flexible
sigmoidoscopy
We found this trial at
1
site
1215 Lee St
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
(434) 924-0211
Phone: 434-924-5621
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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