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

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

Study Overview

• Status: Recruiting
• Conditions: Clostridium Difficile Infection; Microbiome; Clostridium Difficile; CDI
• Intervention / Treatment: Other: No Intervention

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jordan Daniels; Phone Number: 18053390549; Email: jordan@progenabiome.com

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • Recruiting
      • ProgenaBiome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with C. difficile infection

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with CDI; Patients who are infected with C. diff	Other: No Intervention; There is no intervention for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ProgenaBiome

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections
• Other Study ID Numbers: PRG-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Only aggregated deidentified data will be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No