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

Completed

• Conditions: Clostridioides Difficile Infection

• Registration Number: NCT04668014
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-16
• Primary Completion: 2020-12-23
• Study Completion: 2020-12-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of C. difficile within the sigmoid colonic mucosal tissue	1 day (At time of biopsy)	C. difficile identified on fluorescence microscopy via FISH staining

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States