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

• Conditions: CDI; Microbiome; Clostridium Difficile Infection; Clostridium Difficile
• Interventions: Other: No Intervention

• Registration Number: NCT04100603
• Lead Sponsor: ProgenaBiome

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.

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Study Start: 2020-03-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-03
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with CDI	No Intervention	Patients who are infected with C. diff

Primary Outcome Measures

Name	Time	Method
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing	1 year	Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with C. diff infection

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States