NCT04679324

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Typical duration for all trials

Status
withdrawn

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
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

2.9 years

First QC Date

December 9, 2020

Last Update Submit

November 28, 2022

Conditions

Clostridioides Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • Disease recurrence

    Based on clinical stool testing and symptoms

    8 weeks post treatment of C.difficile infection

Secondary Outcomes (1)

  • Change in mucosal presence of C. difficile

    Baseline, approximately 1-14 days post treatment of C. difficile infection

Eligibility Criteria

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

Patients recently diagnosed with C. difficile infection (not defined as recurrent) without underlying inflammatory GI conditions

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Sigmoid colon biopsies, stool samples, blood

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
0

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 22, 2020

Study Start

September 23, 2019

Primary Completion

August 10, 2022

Study Completion

August 10, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share