The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridioides Difficile Infection

Withdrawn

• Conditions: Clostridioides Difficile Infection

• Registration Number: NCT04679324
• 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 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 Timeline

• Study Start: 2019-09-23
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Primary Completion: 2022-08-10
• Study Completion: 2022-08-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults aged 18 and over
• Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease recurrence	8 weeks post treatment of C.difficile infection	Based on clinical stool testing and symptoms

Secondary Outcome Measures

Name	Time	Method
Change in mucosal presence of C. difficile	Baseline, approximately 1-14 days post treatment of C. difficile infection	Identification of C. difficile within the colonic mucosa on stained slides from sigmoid biopsy samples