Clostridioides Difficile Infection
Conditions
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 treated for C. difficile infection to determine if there are features associated with recurrent disease.
Detailed 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.
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal presence | 1-14 days post C. Difficile treatment | Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples |
| Disease recurrence | 8 weeks | Determination of recurrent C. difficile infection based on symptoms and potential clinical testing |
Countries
United States
Outcome results
None listed