Intestinal Bacteria and Ocular Inflammatory Disease

Plain-language summary

This study investigates the relationship between intestinal bacteria and eye inflammation (uveitis). It included patients over 18 with uveitis and healthy volunteers. It is an observational (non-phase) study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

National Eye Institute (NEI)

Start date

8/27/2013

Countries

United States

Related genes

Locations

• Bethesda, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

* 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.