The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-23

Study Completion Date

2022-05-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Clostridioides Difficile Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No