Intestinal Bacteria and Ocular Inflammatory Disease

NCT01859299 | Completed

• 2 other identifiers: 13007213-EI-0072
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveitis

Keywords

Oral Tolerance; Uveitis; AMD; Natural History

Outcome Measures

Primary Outcomes (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).

  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).

  ongoing

Secondary Outcomes (3)

• Abundance differences between groups at the level of individual phylotypes

  ongoing

• Abundance of microbial modules

  ongoing

• Differences in lymphocyte and monocyte activation by different bacterial populations from the human microbiome results

  ongoing

Study Arms (2)

Affected

Participants with various types of uveitis

Healthy controls

Participants without uveitis

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 participants: 150 with uveitis; 50 healthy controls

You may qualify if:

• Participant must be 18 years of age or older.
• Participant must have a diagnosis of:
• Uveitis (or ocular inflammatory disorder)
• 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.

You may not qualify if:

• 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
• Participant has any GI tract surgery leaving permanent residua (e.g., gastrectomy; bariatric surgery; colectomy)
• Participant has inflammatory bowel disease (IBD)
• Participant is pregnant or lactating.
• 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

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 9152063 BACKGROUND

• 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.

  PMID: 21698720 BACKGROUND

• 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.

  PMID: 20534432 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Emily Y Chew, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 21, 2013
• Study Start: August 27, 2013
• Primary Completion: June 29, 2022
• Last Updated: March 27, 2026

Record last verified: 2025-11-24

Locations

US (1)