NCT04668014

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2020

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

December 9, 2020

Last Update Submit

July 7, 2023

Conditions

Clostridioides Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • Presence of C. difficile within the sigmoid colonic mucosal tissue

    C. difficile identified on fluorescence microscopy via FISH staining

    1 day (At time of biopsy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults undergoing screening colonoscopy who have no history of C. difficile infection

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Sigmoid colon biopsies

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Purna Kashyap, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 16, 2020

Study Start

September 1, 2019

Primary Completion

December 23, 2020

Study Completion

December 23, 2020

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)