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NCT04100603 Clinical Trial

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

Clostridium Difficile Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04100603
Other study ID # PRG-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2, 2020
Est. completion date July 31, 2023

Study information
Verified date September 2021
Source ProgenaBiome
Contact Sabine Hazan, MD
Phone 18053390549
Email drsabinehazan@progenabiome.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 31, 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
There is no intervention for this study

Locations
Country Name City State
United States ProgenaBiome Ventura California

Sponsors (1)
Lead Sponsor Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing 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 1 year
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