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NCT04668014 Clinical Trial

The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection

Clostridioides Difficile Infection Clinical Trial

Official title:
The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04668014
Other study ID # 19-005228
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 23, 2020

Study information
Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This research is being done to study the ability of C. difficile to colonize the colonic mucosa of individuals with no prior history of C. difficile infection.

Description:

The ability of C. difficile to colonize the mucosa of the colon will be studied in healthy individuals with no history of C. difficile infection who are undergoing colonoscopy for colon cancer/polyp screening purposes.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 23, 2020
Est. primary completion date December 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults aged 18 and over - No history of C. difficile infection - Undergoing clinically indicated colonoscopy for colon cancer screening or colon polyp surveillance purposes in the absence of active GI symptoms. Exclusion Criteria: - Known active pregnancy - Other known active gastrointestinal infectious process - Inflammatory gastrointestinal conditions (microscopic colitis, inflammatory bowel disease, Celiac disease) - 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
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of C. difficile within the sigmoid colonic mucosal tissue C. difficile identified on fluorescence microscopy via FISH staining 1 day (At time of biopsy)
See also
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Terminated NCT05526807 - Ursodeoxycholic Acid in C. Difficile Infection N/A
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Terminated NCT04802837 - Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects Phase 3
Active, not recruiting NCT04885946 - Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection N/A
Recruiting NCT04305769 - Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) Phase 2
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Active, not recruiting NCT04781387 - Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection Phase 2
Completed NCT03595566 - To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection Phase 3
Completed NCT03595553 - Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection Phase 3
Completed NCT04725123 - Addressing Personalized Needs in Clostridioides Difficile Infection N/A
Not yet recruiting NCT05852587 - Xylitol Use for Decolonization of C. Difficile in Patients With IBD Phase 1
Completed NCT03788434 - Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 2
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