Intestinal Bacteria and Ocular Inflammatory Disease
United States131 participantsStarted 2013-08-27
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be 18 years of age or older.
. Participant must have a diagnosis of:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied whether the gut bacteria of people with uveitis are different from those without — has any research since this study completed started to explain what that connection might actually mean for how uveitis develops or is treated?
2Since this was an observational study measuring microbial composition rather than testing a treatment, are there any follow-up trials now looking at whether changing gut bacteria — through diet, probiotics, or other means — might actually help manage uveitis?
3This study compared groups using a statistical method called UniFrac to analyze gut bacteria patterns — does my specific type of uveitis match the kind of patients who were enrolled, and would my doctor consider my gut health relevant to my care right now?
4Given that this trial is completed but focused on understanding a biological relationship rather than proving a treatment works, should I be cautious about anyone suggesting gut-based therapies for my uveitis based on this kind of early-stage research?
5Are there any currently active trials building on what this gut bacteria and uveitis study found that my doctor thinks might be worth looking into for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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).
. Participant must understand and sign the protocol s informed consent document.
Exclusion criteria
. 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