Clostridium DifficileNCT02797288
Immune Response to C.Difficile Infection
An observational study of Clostridium Difficile, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- -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)
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- Past CDI cohort
- Past CDI diagnosis and current PCR negative fecal samples
- Optional diagnostic colonoscopy for clinical care
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
William A. Petri, MD,PhD, 434-924-5621, wap3g@virginia.edu
About this study
Official title: Clostridioides Difficile and Immune Responses in Acute CDI and Fecal Microbiota Transplant
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.
- Conditions
- Clostridium Difficile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptive immune response
Assessment of adaptive immunity including Th1, Th2 and TH17 immune response
Measured: 0-60 days post enrollment
Secondary outcomes (6)
Changes in gut health
Association of biomarkers in stool and biopsy specimens with CDI outcome
Measured: 0-60 days post enrollment
Gene expression of immune cells in colon
Profiling colonic gene expression and mucosal immune pathways in CDI
Measured: 0-60 days post enrollment
Microbiome
Tissue 16s rDNA
Measured: 0-60 days post enrollment
Immunohistochemistry
Changes in mucosal immunity following FMT
Measured: 0-60 days post enrollment
Antibody response to C. difficile infection
IgG and IgA to C. difficile antigens in plasma and stool
Measured: 0-60 days post enrollment
High dimensional flow-cytometry
Profiling of immune cells in blood and biopsy
Measured: 0-60 days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start22 Mar 2017
- Primary completion31 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Petri, MD, PhD, University of Virginia
- Investigators
- William A. Petri, MD,PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797288
- Sponsor's protocol ID
- 18782
- Other IDs
- R01AI124214-01
- Status last verified
- Sep 2023
- First submitted
- 27 May 2016
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clostridioides Difficile and Immune Responses in Acute CDI and Fecal Microbiota Transplant
- ClinicalTrials.gov ID
- NCT02797288
- Acronym / sponsor ID
- 18782
- Conditions
- Clostridium Difficile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- -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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adaptive immune response
Time frame: 0-60 days post enrollment
Assessment of adaptive immunity including Th1, Th2 and TH17 immune response
6 secondary outcomes
Changes in gut health
Time frame: 0-60 days post enrollment
Gene expression of immune cells in colon
Time frame: 0-60 days post enrollment
Microbiome
Time frame: 0-60 days post enrollment
Immunohistochemistry
Time frame: 0-60 days post enrollment
Antibody response to C. difficile infection
Time frame: 0-60 days post enrollment
High dimensional flow-cytometry
Time frame: 0-60 days post enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 41252206Moreau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William A. Petri, MD,PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William A. Petri, MD,PhD (434-924-5621, wap3g@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptive immune response (time frame: 0-60 days post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02797288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.