Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02797288
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
William Petri, MD, University of Virginia

Tracking Information
First Submitted Date May 27, 2016
First Posted Date June 13, 2016
Last Update Posted Date October 3, 2019
Actual Study Start Date March 22, 2017
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2016)
tissue IL-25 [ Time Frame: 0-60 days post fecal transplant ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 7, 2016)
  • Tissue IL-4 [ Time Frame: 0-60 days post fecal transplant ]
  • Tissue IL-1 [ Time Frame: 0-60 days post fecal transplant ]
  • Tissue histology [ Time Frame: 0-60 days post fecal transplant ]
  • Tissue 16s rDNA [ Time Frame: 0-60 days post fecal transplant ]
  • Plasma metabolomics [ Time Frame: 0-60 days post fecal transplant ]
  • Tissue eosinophils [ Time Frame: 0-60 days post fecal transplant ]
    single-cell atomic mass spectrometry
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immune Response to FMT for C.Difficile
Official Title Role of Eosinophils in Innate Protection From C. Difficile
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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Colon biopsies
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
Condition Clostridium Difficile
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 7, 2016)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: William A. Petri, MD,PhD 434-924-5621 wap3g@virginia.edu
Contact: Jennifer White, BSN 434-982-3649 jaw9r@virginia.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02797288
Other Study ID Numbers 18782
R01AI124214-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party William Petri, MD, University of Virginia
Study Sponsor University of Virginia
Collaborators National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: William A. Petri, MD,PhD University of Virginia
PRS Account University of Virginia
Verification Date October 2019