Immune Response to C.Difficile Infection

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.

Conditions

Clostridium Difficile

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Study Overview

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Study Details

Study overview

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.

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

Immune Response to C.Difficile Infection

Condition
Clostridium Difficile
Intervention / Treatment

-

Contacts and Locations

Charlottesville

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Acute CDI diagnosis including PCR positive fecal samples
  • * Optional diagnostic colonoscopy for clinical care
  • * At least one relapse or recurrence of C. difficile infection
  • * Eligible for fecal microbiota transplant (FMT)
  • * Past CDI diagnosis and current PCR negative fecal samples
  • * Optional diagnostic colonoscopy for clinical care
  • * 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
  • * Unwilling to participate in follow-up phone call at 60-90 days
  • * 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.
  • * Clinical contraindication to colonoscopy or conscious sedation
  • * Pregnancy
  • * Inability to give informed consent unless a legally authorized representative (LAR) is available
  • * Incarceration
  • * HIV infection
  • * 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
  • * Unwilling to provide blood samples for research
  • * 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.
  • * Clinical contraindication to sigmoidoscopy or conscious sedation
  • * Pregnancy
  • * Inability to give informed consent
  • * Incarceration
  • * HIV infection
  • * Neutropenia (\<1000 PMNs/µl blood)
  • * 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
  • * 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.
  • * Clinical contraindication to colonoscopy or conscious sedation
  • * Pregnancy
  • * Inability to give informed consent unless a legally authorized representative (LAR) is available
  • * Incarceration
  • * HIV infection

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Virginia,

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

Study Record Dates

2025-01-01