Status:
WITHDRAWN
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection
Lead Sponsor:
ProgenaBiome
Conditions:
Clostridium Difficile
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Brief Summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
Detailed Description
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with C. diff.
Eligibility Criteria
Inclusion
- Willingness to sign informed consent
- Diagnosis of C. difficile infection
- Age of 18 and older
Exclusion
- 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
Key Trial Info
Start Date :
March 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04100603
Start Date
March 2 2020
End Date
July 31 2030
Last Update
June 5 2025
Active Locations (1)
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1
ProgenaBiome
Ventura, California, United States, 93003