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

ProgenaBiome

Status: Withdrawn

Conditions: CDI; Microbiome; Clostridium Difficile; Clostridium Difficile Infection

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04100603

PRG-004

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Patients with CDI

Description:

Patients who are infected with C. diff

Treatment:

Other: No Intervention