A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2030-07-31

Brief Summary

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This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

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Detailed Description

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The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with C. diff.

Conditions

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Clostridium Difficile Clostridium Difficile Infection Microbiome CDI

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with CDI

Patients who are infected with C. diff

No Intervention

Intervention Type OTHER

There is no intervention for this study

Interventions

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No Intervention

There is no intervention for this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Willingness to sign informed consent
* Diagnosis of C. difficile infection
* Age of 18 and older

Exclusion Criteria

* Refusal by patient to sign informed consent form
* Treatment with antibiotics 2 weeks prior to screening
* Treatment with probiotics 6 weeks prior to screening
* History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
* Postoperative stoma, ostomy, or ileoanal pouch
* Participation in any experimental drug protocol within the past 12 weeks
* Treatment with total parenteral nutrition
* Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
* Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No