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Immune Response to FMT for C.Difficile

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02797288
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : October 3, 2019
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
William Petri, MD, University of Virginia

Brief Summary:
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

Condition or disease
Clostridium Difficile

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Role of Eosinophils in Innate Protection From C. Difficile
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Primary Outcome Measures :
  1. tissue IL-25 [ Time Frame: 0-60 days post fecal transplant ]

Secondary Outcome Measures :
  1. Tissue IL-4 [ Time Frame: 0-60 days post fecal transplant ]
  2. Tissue IL-1 [ Time Frame: 0-60 days post fecal transplant ]
  3. Tissue histology [ Time Frame: 0-60 days post fecal transplant ]
  4. Tissue 16s rDNA [ Time Frame: 0-60 days post fecal transplant ]
  5. Plasma metabolomics [ Time Frame: 0-60 days post fecal transplant ]
  6. Tissue eosinophils [ Time Frame: 0-60 days post fecal transplant ]
    single-cell atomic mass spectrometry

Biospecimen Retention:   Samples With DNA
Colon biopsies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients receiving fecal transplant for recurrent Clostridium difficile infection identified from the University of Virginia complicated Clostridium difficile clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02797288

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Contact: William A. Petri, MD,PhD 434-924-5621
Contact: Jennifer White, BSN 434-982-3649

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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
Contact: William A. Petri, MD,PhD    434-924-5621   
Sponsors and Collaborators
University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: William A. Petri, MD,PhD University of Virginia
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Responsible Party: William Petri, MD, Chief, Infectious Diseases & International Health, University of Virginia Identifier: NCT02797288    
Other Study ID Numbers: 18782
R01AI124214-01 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No