The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridiodes Difficile Infection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Clostridioides Difficile Infection
- Sponsor
- Mayo Clinic
- Primary Endpoint
- Disease recurrence
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
Purna C. Kashyap, MBBS
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
Time Frame: 8 weeks post treatment of C.difficile infection
Based on clinical stool testing and symptoms
Secondary Outcomes
- Change in mucosal presence of C. difficile(Baseline, approximately 1-14 days post treatment of C. difficile infection)