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NCT04675723 Clinical Trial

The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

Clostridioides Difficile Infection Clinical Trial

Official title:
The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04675723
Other study ID # 19-005227
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 23, 2019
Est. completion date May 5, 2022

Study information
Verified date January 2023
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 treated for C. difficile infection to determine if there are features associated with recurrent disease.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date May 5, 2022
Est. primary completion date May 5, 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 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.

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 Mucosal presence Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples 1-14 days post C. Difficile treatment
Primary Disease recurrence Determination of recurrent C. difficile infection based on symptoms and potential clinical testing 8 weeks
See also
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Completed NCT04668014 - The Characteristics and Role of Mucosal Microbiome After Treatment of Clostridioides Difficile Infection
Completed NCT03183141 - ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection Phase 3
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Terminated NCT05526807 - Ursodeoxycholic Acid in C. Difficile Infection N/A
Recruiting NCT06306014 - Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients Phase 1/Phase 2
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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
Recruiting NCT06106698 - Washed Microbiota Transplantation for Clostridioides Difficile Infection
Active, not recruiting NCT04781387 - Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection Phase 2
Completed NCT03595553 - Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection Phase 3
Completed NCT03595566 - To Compare 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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