Understanding the immune response to Clostridium difficile infection
Clostridioides Difficile and Immune Responses in Acute CDI and Fecal Microbiota Transplant
University of Virginia · NCT02797288
This study looks at how the immune system responds to Clostridium difficile infections to see if understanding this can lead to better treatments for people with these infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT02797288 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the immune mechanisms involved in Clostridium difficile infections (CDI), focusing on the Th17 response and Type II immunity's role in protecting the gut from toxin-induced damage. It includes three cohorts: hospitalized patients with acute CDI, outpatients with recurrent CDI scheduled for fecal microbiota transplant (FMT), and inpatients with a history of CDI but no recurrence. Blood and stool samples will be collected for analysis, and follow-up will assess relapse or mortality rates. The findings aim to inform new treatment strategies for CDI beyond current methods.
Who should consider this trial
Good fit: Ideal candidates include adults with acute CDI, recurrent CDI eligible for FMT, or those with a past history of CDI without recurrence.
Not a fit: Patients who are unwilling to undergo research biopsies or provide samples, or those with contraindications to colonoscopy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to innovative treatments or preventive measures for Clostridium difficile colitis.
How similar studies have performed: Other studies have shown promise in understanding immune responses to CDI, but this specific approach is novel and aims to explore new therapeutic avenues.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlottesville, Virginia
- University of Virginia Health System — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: William A. Petri, MD,PhD — University of Virginia
- Study coordinator: William A. Petri, MD,PhD
- Email: wap3g@virginia.edu
- Phone: 434-924-5621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clostridium Difficile