Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
131 participants
OBSERVATIONAL
2013-08-27
Brief Summary
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\- 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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Affected
Participants with various types of uveitis
No interventions assigned to this group
Healthy controls
Participants without uveitis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
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
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.
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.
18 Years
120 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Responsible Party
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Principal Investigators
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Emily Y Chew, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Eye Institute (NEI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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References
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Nussenblatt RB, Gery I, Weiner HL, Ferris FL, Shiloach J, Remaley N, Perry C, Caspi RR, Hafler DA, Foster CS, Whitcup SM. Treatment of uveitis by oral administration of retinal antigens: results of a phase I/II randomized masked trial. Am J Ophthalmol. 1997 May;123(5):583-92. doi: 10.1016/s0002-9394(14)71070-0.
Presley LL, Ye J, Li X, Leblanc J, Zhang Z, Ruegger PM, Allard J, McGovern D, Ippoliti A, Roth B, Cui X, Jeske DR, Elashoff D, Goodglick L, Braun J, Borneman J. Host-microbe relationships in inflammatory bowel disease detected by bacterial and metaproteomic analysis of the mucosal-luminal interface. Inflamm Bowel Dis. 2012 Mar;18(3):409-17. doi: 10.1002/ibd.21793. Epub 2011 Jun 22.
Caporaso JG, Lauber CL, Walters WA, Berg-Lyons D, Lozupone CA, Turnbaugh PJ, Fierer N, Knight R. Global patterns of 16S rRNA diversity at a depth of millions of sequences per sample. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4516-22. doi: 10.1073/pnas.1000080107. Epub 2010 Jun 3.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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13-EI-0072
Identifier Type: -
Identifier Source: secondary_id
130072
Identifier Type: -
Identifier Source: org_study_id