Immune Response to C.Difficile Infection

Launched by UNIVERSITY OF VIRGINIA · Jun 7, 2016

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system responds to Clostridium difficile (C. difficile) infections, which can cause severe diarrhea and other complications. Researchers want to understand how certain immune responses can influence the severity of these infections and how specific types of immunity can help protect the gut. The ultimate goal is to find new and effective treatments for C. difficile infections, especially for those who have had multiple episodes and may benefit from a procedure called fecal microbiota transplant (FMT), which helps restore healthy gut bacteria.

To participate in this trial, you need to be between the ages of 65 and 74 and have a diagnosis of an acute C. difficile infection, or have experienced a relapse. If you have previously had a C. difficile infection but are currently feeling better, you may also be eligible. Participants will undergo tests, including blood and stool sample collections, and may have a colonoscopy for both clinical care and research purposes. It’s important to note that this trial may not be suitable for individuals who are pregnant, have certain medical conditions, or are currently participating in other clinical trials. If you choose to join, you'll be contributing to valuable research that could lead to better treatments for those affected by this infection.

Gender

ALL

Eligibility 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