The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

Mayo Clinic52 enrolled

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 treated for C. difficile infection to determine if there are features associated with recurrent disease.

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 Type

OBSERVATIONAL

Enrollment

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 pregnancy * Prior diagnosis of C. difficile infection within 2 months of this diagnosis * Other known active gastrointestinal infectious process * Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions * 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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Mucosal presence

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

Time frame: 1-14 days post C. Difficile treatment

Disease recurrence

Determination of recurrent C. difficile infection based on symptoms and potential clinical testing

Time frame: 8 weeks

Data from ClinicalTrials.gov

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