CDI, Clostridium Difficile, Clostridium Difficile Infection, Microbiome
Conditions
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.
Interventions
OTHERNo Intervention
There is no intervention for this study
Sponsors
ProgenaBiome
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed