The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

Mayo Clinic

Status: Completed

Conditions: Clostridioides Difficile Infection

Study type: Observational

Funder types: Other

Identifiers

NCT04675723

19-005227

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.