Clostridioides Difficile InfectionNCT04675723
The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection
An observational study of Clostridioides Difficile Infection, run by Mayo Clinic at 1 site in United States.
Trial summary
The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for C. difficile infection to determine if there are features associated with recurrent disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 5 May 2022
- 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: Patients without known underlying inflammatory GI conditions with recent diagnosis and treatment of C. difficile infection, for whom the recent diagnosis was not that of recurrent disease already
Who may be able to join
- Adults aged 18 and over
- Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea
Who cannot join
- Known pregnancy
- Prior diagnosis of C. difficile infection within 2 months of this diagnosis
- Other known active gastrointestinal infectious process
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions
- Vulnerable adults
- Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for C. difficile infection to determine if there are features associated with recurrent disease.
Read the detailed description
Patients who have recently been diagnosed with C. difficile infection and completed treatment will be enrolled to undergo evaluation of the colonic mucosa via sigmoid biopsies. Participants will also complete surveys, blood draw and stool collection. Overall goals are to identify whether C. difficile is persisting in the colon mucosa after treated infection, and whether this, and other clinical and microbiome factors may be playing a role in disease recurrence.
- Conditions
- Clostridioides Difficile Infection
- Medical subject headings
- Clostridium Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal presence
Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples
Measured: 1-14 days post C. Difficile treatment
Disease recurrence
Determination of recurrent C. difficile infection based on symptoms and potential clinical testing
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start23 Sep 2019
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Purna C. Kashyap, MBBS, Mayo Clinic
- Investigators
- Purna Kashyap, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675723
- Sponsor's protocol ID
- 19-005227
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection
- ClinicalTrials.gov ID
- NCT04675723
- Acronym / sponsor ID
- 19-005227
- Conditions
- Clostridioides Difficile Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 19 Dec 2020 (actual)
- 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 study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for C. difficile infection to determine if there are features associated with recurrent disease.
Detailed description
Patients who have recently been diagnosed with C. difficile infection and completed treatment will be enrolled to undergo evaluation of the colonic mucosa via sigmoid biopsies. Participants will also complete surveys, blood draw and stool collection. Overall goals are to identify whether C. difficile is persisting in the colon mucosa after treated infection, and whether this, and other clinical and microbiome factors may be playing a role in disease recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without known underlying inflammatory GI conditions with recent diagnosis and treatment of C. difficile infection, for whom the recent diagnosis was not that of recurrent disease already
Key inclusion criteria (2 listed)
- Adults aged 18 and over
- Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea
Key exclusion criteria (6 listed)
- Known pregnancy
- Prior diagnosis of C. difficile infection within 2 months of this diagnosis
- Other known active gastrointestinal infectious process
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions
- Vulnerable adults
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
Mucosal presence
Time frame: 1-14 days post C. Difficile treatment
Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples
Disease recurrence
Time frame: 8 weeks
Determination of recurrent C. difficile infection based on symptoms and potential clinical testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Purna Kashyap, MD principal investigator
Mayo Clinic
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 Clostridioides Difficile Infection, run by Mayo Clinic 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 18 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal presence (time frame: 1-14 days post C. Difficile treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2023.