Intestinal Bacteria and Ocular Inflammatory Disease
United States131 participantsStarted 2013-08-27
Plain-language summary
Background:
\- Uveitis is a general term describing a group of inflammatory diseases of the eye. The causes of uveitis are not fully understood. Researchers want to look at bacteria in the body that might be related to the inflammation. They will study the natural bacteria present in the gut and intestines of people with and without uveitis to understand their potential role in these diseases.
Objectives:
\- To study the intestinal bacteria in people with and without uveitis or ocular inflammatory disease.
Eligibility:
* Individuals at least 18 years of age who have uveitis or ocular inflammatory disease.
* Individuals at least 18 years of age without uveitis or ocular inflammatory disease to serve as healthy controls.
Design:
* Participants may have more than one study visit (approximately 2-4) to assess possible changes in microbiome composition associated with treatment or disease activity.
* At each visit, participants will have a full eye examination, including vision and eye pressure tests. They will provide blood samples for testing. Participants will also be provided a stool collection kit to take home. The samples may be sent or brought back to the clinic.
* Treatment will not be provided as part of this study.
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria
✓. Participant must be 18 years of age or older.
✓. Participant must have a diagnosis of:
✓. Participant must be able to undergo slit lamp biomicroscopy.
✓. Participant must understand and sign the protocol s informed consent document.
✓. Participant must be 18 years of age or older.
✓. Participant must be able to undergo slit lamp biomicroscopy.
✓. Healthy controls will be age-and sex-matched individuals with no personal history of uveitis or other rheumatologic/autoimmune diseases (such as arthritis, inflammatory bowel disease, type 1 diabetes mellitus, psoriasis, Sjorgren s syndrome or multiple sclerosis) and no current use of corticosteroids, disease modifying antirheumatic drugs (DMARDs) including those with antibiotic properties (e.g., gold salts, sulfasalazine, hydroxychloroquine, minocycline) or any immunomodulatory drugs.
✓. Participant must understand and sign the protocol s informed consent document.
Exclusion criteria
What they're measuring
1
The primary outcome is principal component analysis using the unweighted UniFrac distance metric of microbial composition; the significance between groups will be tested by the Adonis method (http://qiime.org/tutorials/category_comparison.html).
✕. Participants who are unable to provide informed consent.
✕. Recent (\<3 months prior) use of any antibiotic therapy
✕. Current consumption of probiotics
✕. Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)
✕. Known gastrointestinal (GI) tract neoplasm
✕. Recent GI tract infection (gastroenteritis, colitis, diverticulitis, appendicitis) within the last month
✕. Chronic unexplained diarrhea
✕. Participant has or had a significant active infection (an infection requiring treatment as determined by the investigator) that required systemic antibiotic treatment within the past three months