This study is NOT currently recruiting participants.
Number
13-EI-0072
Sponsoring Institute
National Eye Institute (NEI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Children;Pregnant Women
Keywords
Oral Tolerance; Uveitis; AMD; Natural History
Recruitment Keyword(s)
None
Condition(s)
Uveitis
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Eye Institute
- 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.
--Back to Top--
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.
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
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.
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.
Principal Investigator
Referral Contact
For more information: