Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT02797288

Conditions

Clostridium Difficile

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Study ID

NCT02797288

Start date

Mar 22, 2017

Status verified date

Sep, 2023

Completion date

Jan 1, 2025

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

-Acute CDI cohort

  • Acute CDI diagnosis including PCR positive fecal samples
  • Optional diagnostic colonoscopy for clinical care

FMT cohort

  • At least one relapse or recurrence of C. difficile infection
  • Eligible for fecal microbiota transplant (FMT)

Past CDI cohort

  • Past CDI diagnosis and current PCR negative fecal samples
  • Optional diagnostic colonoscopy for clinical care

Exclusion Criteria:

Acute CDI cohort:

  • 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

FMT cohort:

  • 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)

Past CDI Control cohort:

  • 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

Study Design

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute CDI cohort

Hospitalized patients diagnosed with Acute CDI

FMT cohort

Patients undergoing FMT for recurrent CDI

Past CDI Control Cohort

Hospitalized patients with past CDI diagnosis without recurrence

Primary outcome measure

  • Adaptive immune response [ Time Frame: 0-60 days post enrollment ]

Central Contacts and Locations

Central contacts

William A. Petri, MD,PhD

434-924-5621wap3g@virginia.edu

Uma Nayak, PhD

434-982-3749un8x@virginia.edu

Locations

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

William A. Petri, MD,PhD

434-924-5621wap3g@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Sep 6, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2023-09-06.