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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04679324

Enrollment

Registered

2020-12-22

Start date

2019-09-23

Completion date

2022-08-10

Last updated

2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridioides Difficile Infection

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Disease recurrence	8 weeks post treatment of C.difficile infection	Based on clinical stool testing and symptoms

Secondary

Measure	Time frame	Description
Change in mucosal presence of C. difficile	Baseline, approximately 1-14 days post treatment of C. difficile infection	Identification of C. difficile within the colonic mucosa on stained slides from sigmoid biopsy samples

Outcome results