The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

Completed

• Conditions: Clostridioides Difficile Infection

• Registration Number: NCT04675723
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study Start: 2019-09-23
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mucosal presence	1-14 days post C. Difficile treatment	Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples
Disease recurrence	8 weeks	Determination of recurrent C. difficile infection based on symptoms and potential clinical testing

Trial Locations

Locations (1)

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