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

NCT04100603 | Withdrawn DMC

• 1 other identifier: PRG-004
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Clostridium Difficile; Clostridium Difficile Infection; Microbiome; CDI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with CDI

Patients who are infected with C. diff

Other: No Intervention

Interventions

No Intervention OTHER

There is no intervention for this study

Patients with CDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with C. difficile infection

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)