Clostridioides Difficile InfectionNCT04679324
The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridioides Difficile Infection
An observational study of Clostridioides Difficile Infection, run by Mayo Clinic.
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 diagnosed with C. difficile infection to determine if there are features associated with development, clearance, and recurrence of 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2019to 10 Aug 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 recently diagnosed with C. difficile infection (not defined as recurrent) without underlying inflammatory GI conditions
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 active pregnancy
- Prior diagnosis of C. difficile infection within 2 months of this diagnosis
- Other known active gastrointestinal infectious process
- 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
About this study
Official title: The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridiodes Difficile Infection
The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been diagnosed with C. difficile infection to determine if there are features associated with development, clearance, and recurrence of disease.
Read the detailed description
Patients who were recently diagnosed with C. difficile infection will undergo assessment of both before treatment and after completing treatment to study the presence of C. difficile in the colonic mucosa pre as well as assessment for microbiome and patient/clinical factors that may contribute to disease recurrence. Assessment will include sigmoid colon biopsies, blood draw, stool samples and surveys.
- 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.
Disease recurrence
Based on clinical stool testing and symptoms
Measured: 8 weeks post treatment of C.difficile infection
Secondary outcomes (1)
Change in mucosal presence of C. difficile
Identification of C. difficile within the colonic mucosa on stained slides from sigmoid biopsy samples
Measured: Baseline, approximately 1-14 days post treatment of C. difficile infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start23 Sep 2019
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Why it stopped: C. difficile symptoms preclude participants from attending research study visits.
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
- 0 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
- NCT04679324
- Sponsor's protocol ID
- 19-005222
- Status last verified
- Nov 2022
- First submitted
- 9 Dec 2020
- Last updated
- 29 Nov 2022
- 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridiodes Difficile Infection
- ClinicalTrials.gov ID
- NCT04679324
- Acronym / sponsor ID
- 19-005222
- Conditions
- Clostridioides Difficile Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: C. difficile symptoms preclude participants from attending research study visits.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 22 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 diagnosed with C. difficile infection to determine if there are features associated with development, clearance, and recurrence of disease.
Detailed description
Patients who were recently diagnosed with C. difficile infection will undergo assessment of both before treatment and after completing treatment to study the presence of C. difficile in the colonic mucosa pre as well as assessment for microbiome and patient/clinical factors that may contribute to disease recurrence. Assessment will include sigmoid colon biopsies, blood draw, stool samples and surveys.
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 recently diagnosed with C. difficile infection (not defined as recurrent) without underlying inflammatory GI conditions
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 (5 listed)
- Known active pregnancy
- Prior diagnosis of C. difficile infection within 2 months of this diagnosis
- Other known active gastrointestinal infectious process
- 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
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
Disease recurrence
Time frame: 8 weeks post treatment of C.difficile infection
Based on clinical stool testing and symptoms
1 secondary outcome
Change in mucosal presence of C. difficile
Time frame: Baseline, approximately 1-14 days post treatment of C. difficile infection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridioides Difficile Infection, run by Mayo Clinic.
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 5 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: withdrawn, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Disease recurrence (time frame: 8 weeks post treatment of C.difficile infection). 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 29 Nov 2022.