The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridioides Difficile Infection

Clostridioides Difficile Infection Clinical Trial

Official title:

The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridiodes Difficile Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04679324
• Other study ID #: 19-005222
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

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

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

External Links

•   Mayo Clinic Clinical Trials