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Status unknownNCT02797288Updated Sep 6, 2023

Immune Response to C.Difficile Infection

An observational study in Clostridium Difficile, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by University of Virginia · Observational

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
360
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The study includes one cohort of hospitalized patients with acute CDI who may require diagnostic colonoscopy, a second cohort of outpatients with recurrent CDI scheduled for FMT and a third cohort of inpatients with past history of CDI without recurrence.

Blood samples and discarded stool samples for research will be obtained from adult hospitalized patients. Biopsies and brushing samples for research will be obtained from patients requiring diagnostic colonoscopies for clinical care. Follow-up will include phone contact at 60-90 days to determine relapse or mortality in acute CDI patients.

Blood and colonic biopsies and brushing samples will be obtained from patients undergoing FMT for recurrent CDI and again after 60 days from convalescent patients.

Blood and biopsies taken for research purposes at each colonoscopy will be analyzed for: cytokines and chemokines, gene expression analysis, immunohistochemistry and high dimensional flow-cytometry.

02

Conditions studied

  • Clostridium Difficile
03

In context

Lead sponsor

University of Virginia is the lead sponsor of 673 studies on the registry; 139 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Browse University of Virginia studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Acute CDI cohort: Hospitalized patients diagnosed with CDI

FMT cohort: Adult patients receiving fecal transplant for recurrent CDI identified from the University of Virginia complicated Clostridium difficile clinic

Past CDI Control cohort: Hospitalized patients with past CDI without recurrence

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
360 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Adaptive immune response

    Assessment of adaptive immunity including Th1, Th2 and TH17 immune response

    Time frame: 0-60 days post enrollment

Secondary outcomes

  1. Changes in gut health

    Association of biomarkers in stool and biopsy specimens with CDI outcome

    Time frame: 0-60 days post enrollment

  2. Gene expression of immune cells in colon

    Profiling colonic gene expression and mucosal immune pathways in CDI

    Time frame: 0-60 days post enrollment

  3. Microbiome

    Tissue 16s rDNA

    Time frame: 0-60 days post enrollment

  4. Immunohistochemistry

    Changes in mucosal immunity following FMT

    Time frame: 0-60 days post enrollment

  5. Antibody response to C. difficile infection

    IgG and IgA to C. difficile antigens in plasma and stool

    Time frame: 0-60 days post enrollment

  6. High dimensional flow-cytometry

    Profiling of immune cells in blood and biopsy

    Time frame: 0-60 days post enrollment

07

Study locations

1 of 1 sites recruiting
  • University of Virginia Health System
    Charlottesville, Virginia 22903, United States
    Recruiting
08

References and documents

Publications

  • Moreau GB, Tian J, Natale NR, Naz F, Young MK, Nayak U, Tanyuksel M, Rigo I, Madden GR, Abhyankar MM, Hagspiel N, Brovero S, Worthington M, Behm B, Marie C, Petri WA Jr, Ramakrishnan G. Fecal microbiota transplantation promotes type 2 mucosal immune responses with colonic epithelium proliferation in patients with recurrent Clostridioides difficile. JCI Insight. 2025 Nov 18;11(1):e195678. doi: 10.1172/jci.insight.195678. eCollection 2026 Jan 9. PubMed 41252206 ↗

Study documents

  • Informed consent form · Jan 24, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02797288
Lead sponsor
University of Virginia
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
William Petri, MD, PhD (Vice Chair, Department of Medicine, University of Virginia) — Principal investigator
First posted
Jun 13, 2016
Start date
Mar 22, 2017
Primary completion
Oct 31, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Sep 6, 2023

Study contacts

William A. Petri, MD,PhD
Contact
wap3g@virginia.edu
434-924-5621
Uma Nayak, PhD
Contact
un8x@virginia.edu
434-982-3749
William A. Petri, MD,PhD
principal investigator · University of Virginia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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