A Pilot Study to Explore the Role of Gut Flora in Rheumatoid Arthritis
Study Details
Study Description
Brief Summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Rheumatoid Arthritis
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Rheumatoid Arthritis.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patients Patients who have been diagnosed with Rheumatoid Arthritis |
Other: No Intervention
There is no intervention for this study
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Outcome Measures
Primary Outcome Measures
- Correlation of Microbiome to Disease via Relative Abundance and Presence of Absence of Specific Bacterial Species Found in Microbiome Sequencing [One year]
The identification of bacterial species residing the gut flora will be processed by next generation sequencing followed by metagenomic analysis. Bacterial diversity will then be evaluated in parallel with relative abundance of targeted species within and among individual microbes. For example, in examining the class clostridia looking at the species Clostridioides difficile and seeing what proportion of the Clostridia is represented by C. difficile.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
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Male or female patients of any age (interest is given to children to compare with mothers).
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Diagnosis of Rheumatoid Arthritis
Exclusion Criteria:
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Refusal to sign informed consent form
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History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
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Postoperative stoma, ostomy, or ileoanal pouch
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Participation in any experimental drug protocol within the past 12 weeks
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Treatment with total parenteral nutrition
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Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
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Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | ProgenaBiome | Ventura | California | United States | 93003 |
Sponsors and Collaborators
- ProgenaBiome
Investigators
- Principal Investigator: Sabine Hazan, MD, ProgenaBiome
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRG-026