NCT02797288

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

7.6 years

First QC Date

May 27, 2016

Last Update Submit

September 3, 2023

Conditions

Clostridium Difficile

Outcome Measures

Primary Outcomes (1)

  • Adaptive immune response

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

    0-60 days post enrollment

Secondary Outcomes (6)

  • Changes in gut health

    0-60 days post enrollment

  • Gene expression of immune cells in colon

    0-60 days post enrollment

  • Microbiome

    0-60 days post enrollment

  • Immunohistochemistry

    0-60 days post enrollment

  • Antibody response to C. difficile infection

    0-60 days post enrollment

  • +1 more secondary outcomes

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • Clinical contraindication to sigmoidoscopy or conscious sedation
  • Pregnancy
  • Inability to give informed consent
  • Incarceration
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41252206DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, and Colon biopsies and brushings

Study Officials

  • William A. Petri, MD,PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William A. Petri, MD,PhD

CONTACT

434-924-5621wap3g@virginia.edu

Uma Nayak, PhD

CONTACT

434-982-3749un8x@virginia.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair, Department of Medicine

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 13, 2016

Study Start

March 22, 2017

Primary Completion

October 31, 2024

Study Completion

January 1, 2025

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)