Intestinal Bacteria and Ocular Inflammatory Disease
- Conditions
- Uveitis
- Registration Number
- NCT01859299
- Lead Sponsor
- National Eye Institute (NEI)
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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).
- Secondary Outcome Measures
Name Time Method Abundance differences between groups at the level of individual phylotypes ongoing Abundance differences between groups at the level of individual phylotypes (at different taxonomic levels, from phylum to species); the significance between groups will be tested using ANOVA
Abundance of microbial modules ongoing abundance of microbial modules, constructed from microbial abundance co-occurrence networks and weighted gene co-expression network analysis (WGCNA) methodology, using the module eigenvector as the quantitative metric and statistically tested by ANOVA
Differences in lymphocyte and monocyte activation by different bacterial populations from the human microbiome results ongoing Differences in lymphocyte and monocyte activation by different bacterial populations from the human microbiome results
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States