RECRUITING

Immune Response to C.Difficile Infection

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Conditions

Clostridium Difficile

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by identifying how a Th 17 response impacts severity of C. difficile infection and how Type II immunity protects the gut from Clostridium difficile toxin-induced 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 microbial transplantation will restore protective immunity to recurrent C.difficile infection.

Official Title

Clostridioides Difficile and Immune Responses in Acute CDI and Fecal Microbiota Transplant

Quick Facts

Study Start:2017-03-22
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02797288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Acute CDI diagnosis including PCR positive fecal samples
  2. * Optional diagnostic colonoscopy for clinical care
  3. * At least one relapse or recurrence of C. difficile infection
  4. * Eligible for fecal microbiota transplant (FMT)
  5. * Past CDI diagnosis and current PCR negative fecal samples
  6. * Optional diagnostic colonoscopy for clinical care
  1. * Unwilling to have research biopsies and brushings at time of diagnostic colonoscopy; Unwilling to provide blood and stool samples (discarded stool from UVA lab) for research
  2. * Unwilling to participate in follow-up phone call at 60-90 days
  3. * Concurrent participation in another clinical trial. This exclusion does not apply to participation in IRB-HSR #200046 and non-interventional research studies. Concurrent participation in non-interventional research studies is allowed.
  4. * Clinical contraindication to colonoscopy or conscious sedation
  5. * Pregnancy
  6. * Inability to give informed consent unless a legally authorized representative (LAR) is available
  7. * Incarceration
  8. * HIV infection
  9. * Unwilling to have research biopsies and brushings and stool samples at time of colonoscopy with FMT for clinical care and research sigmoidoscopy at Day 60
  10. * Unwilling to provide blood samples for research
  11. * Concurrent participation in another clinical trial This exclusion does not apply to participation in non-interventional research studies. Concurrent participation in non-interventional research studies is allowed.
  12. * Clinical contraindication to sigmoidoscopy or conscious sedation
  13. * Pregnancy
  14. * Inability to give informed consent
  15. * Incarceration
  16. * HIV infection
  17. * Neutropenia (\<1000 PMNs/µl blood)
  18. * Unwilling to have research biopsies and brushings at time of diagnostic colonoscopy; Unwilling to provide blood and stool samples (discarded stool from UVA lab) for research
  19. * Concurrent participation in another clinical trial. This exclusion does not apply to participation in IRB-HSR #200046 and non-interventional research studies. Concurrent participation in non-interventional research studies is allowed.
  20. * Clinical contraindication to colonoscopy or conscious sedation
  21. * Pregnancy
  22. * Inability to give informed consent unless a legally authorized representative (LAR) is available
  23. * Incarceration
  24. * HIV infection

Contacts and Locations

Study Contact

William A. Petri, MD,PhD
CONTACT
434-924-5621
wap3g@virginia.edu
Uma Nayak, PhD
CONTACT
434-982-3749
un8x@virginia.edu

Principal Investigator

William A. Petri, MD,PhD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia Health System
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • William A. Petri, MD,PhD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-22
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2017-03-22
Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Clostridium Difficile