NCT04675723

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 treated for C. difficile infection to determine if there are features associated with recurrent disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2.6 years

First QC Date

December 9, 2020

Last Update Submit

January 17, 2023

Conditions

Clostridioides Difficile Infection

Outcome Measures

Primary Outcomes (2)

  • Mucosal presence

    Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples

    1-14 days post C. Difficile treatment

  • Disease recurrence

    Determination of recurrent C. difficile infection based on symptoms and potential clinical testing

    8 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients without known underlying inflammatory GI conditions with recent diagnosis and treatment of C. difficile infection, for whom the recent diagnosis was not that of recurrent disease already

You may qualify if:

  • Adults aged 18 and over
  • Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Purna Kashyap, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 19, 2020

Study Start

September 23, 2019

Primary Completion

May 5, 2022

Study Completion

May 5, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)