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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Clostridioides Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections
• Recurrence

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

External Links

•   Mayo Clinic Clinical Trials