The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection

NCT ID: NCT04668014

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research is being done to study the ability of C. difficile to colonize the colonic mucosa of individuals with no prior history of C. difficile infection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ability of C. difficile to colonize the mucosa of the colon will be studied in healthy individuals with no history of C. difficile infection who are undergoing colonoscopy for colon cancer/polyp screening purposes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clostridioides Difficile Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults aged 18 and over
* No history of C. difficile infection
* Undergoing clinically indicated colonoscopy for colon cancer screening or colon polyp surveillance purposes in the absence of active GI symptoms.

Exclusion Criteria

* Known active pregnancy
* Other known active gastrointestinal infectious process
* Inflammatory gastrointestinal conditions (microscopic colitis, inflammatory bowel disease, Celiac disease)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Purna C. Kashyap, MBBS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Purna Kashyap, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-005228

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clostridioides Difficile Colonisation
NCT05693077 UNKNOWN PHASE1
FMT in Uncomplicated Diverticulitis
NCT05373784 ACTIVE_NOT_RECRUITING EARLY_PHASE1
Early FMT for C.Difficile
NCT02465463 COMPLETED PHASE1/PHASE2
Freeze-dried, Capsulized FMT for RCDI
NCT02399618 UNKNOWN PHASE1
MTC Versus FMT in for RCDI
NCT05911997 RECRUITING PHASE1
C.Difficile Observational Study
NCT06277999 COMPLETED
CMTS0929 for Clostridioides Difficile Infection
NCT06836427 NOT_YET_RECRUITING EARLY_PHASE1