Intestinal Bacteria and Ocular Inflammatory Disease

Objective: What precipitates ocular inflammatory episodes remains unknown, but a possible
potentiating factor is the microbiome. The microbiome has become increasingly studied with
the advent of new techniques, but these have not been applied to uveitis. We wish to evaluate
microbiome composition in patients with the ocular inflammatory diseases uveitis who may be
on standard therapy or receiving orally-administered tolerizing antigen therapy.

Study Population: A total of 200 participants may be enrolled in this study. Of those
participants, the goal is to enroll 50 healthy controls and 150 with various types of
uveitis.

Design: This is an observational, prospective, single-center study. Participants will receive
a complete ocular examination with clinical testing as determined clinically and will provide
stool and blood samples using a standardized method. Participants may have multiple visits
and may provide multiple samples in order to evaluate changes in microbiota composition with
disease status or treatment.

Outcome Measures: Alterations in bacterial diversity, microbiota composition and changes in
relative abundance of various taxa or species will be analyzed between healthy volunteers and
participants and between various types of uveitis. In addition, comparisons will be made
between these findings and the immunome and metabolome.

- INCLUSION CRITERIA:

Inclusion Criteria for Uveitis Participants

1. Participant must be 18 years of age or older.

2. Participant must have a diagnosis of:

Uveitis (or ocular inflammatory disorder)

3. Participant must be able to undergo slit lamp biomicroscopy.

4. Participant must understand and sign the protocol s informed consent document.

Inclusion Criteria for Healthy Volunteers

1. Participant must be 18 years of age or older.

2. Participant must be able to undergo slit lamp biomicroscopy.

3. 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.

4. Participant must understand and sign the protocol s informed consent document.

EXCLUSION CRITERIA:

Exclusion Criteria for Uveitis Participants

1. Participants who are unable to provide informed consent.

2. Recent (<3 months prior) use of any antibiotic therapy

3. Current consumption of probiotics

4. Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)

5. Known gastrointestinal (GI) tract neoplasm

6. Recent GI tract infection (gastroenteritis, colitis, diverticulitis, appendicitis)
within the last month

7. Chronic unexplained diarrhea

8. 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

9. Participant has any GI tract surgery leaving permanent residua (e.g., gastrectomy;
bariatric surgery; colectomy)

10. Participant has inflammatory bowel disease (IBD)

11. Participant is pregnant or lactating.

Exclusion Criteria for Healthy Volunteers

1. Recent (<3 months prior) use of any antibiotic therapy

2. Current consumption of probiotics

3. Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)

4. Known gastrointestinal (GI) tract neoplasm

5. Recent GI tract infection (gastroenteritis, colitis, diverticulitis, appendicitis)
within the last month

6. Chronic unexplained diarrhea

7. 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

8. Participant has any GI tract surgery leaving permanent residua (e.g., gastrectomy;
bariatric surgery; colectomy)

9. Participant has inflammatory bowel disease (IBD)

10. Participant is pregnant or lactating.