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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04679324
Other study ID # 19-005222
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 23, 2019
Est. completion date August 10, 2022

Study information

Verified date November 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 10, 2022
Est. primary completion date August 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary Disease recurrence Based on clinical stool testing and symptoms 8 weeks post treatment of C.difficile infection
Secondary Change in mucosal presence of C. difficile Identification of C. difficile within the colonic mucosa on stained slides from sigmoid biopsy samples Baseline, approximately 1-14 days post treatment of C. difficile infection
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