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

Mayo Clinic

Overview

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.

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 Type

OBSERVATIONAL

Conditions

Clostridioides Difficile Infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Disease recurrence

Based on clinical stool testing and symptoms

Time frame: 8 weeks post treatment of C.difficile infection

Secondary Outcomes

Change in mucosal presence of C. difficile

Identification of C. difficile within the colonic mucosa on stained slides from sigmoid biopsy samples

Time frame: Baseline, approximately 1-14 days post treatment of C. difficile infection

Data from ClinicalTrials.gov

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