Microbiome as a ThErapeutic Response Biomarker
Withdrawn before enrolling
Conditions studied: Uveitis
In brief
Background: Uveitis is inflammation inside of the eye. It can cause vision loss. Little is known about the disease. There are few treatment options. Researchers want to learn how the bacteria in the gut might affect how people with uveitis respond to treatment. Objective: To investigate the natural bacteria present in the gut and intestines to study whether it might affect uveitis treatment. Eligibility: People ages 13 and older with non-infectious uveitis who are enrolled in the ADalimumab Vs. conventional ImmunoSupprEssion for uveitis (ADVISE) trial, and their uveitis is being treated or will be treated with an oral corticosteroid, conventional immunosuppressive drugs, or adalimumab. Design: Participants will have 2 study visits at their respective clinical sites. The visits will be 6 months apart. The visits will align with the main ADVISE trial visits. Participants will give blood samples. A needle will be used to take blood from an arm vein. They will also give stool samples. They will get stool collection kits. They will collect each sample at home and send it to the NIH. Participants will complete online diet history questionnaires. They will get an ID and password to access the questionnaires. The ID is a unique code. This means it does not contain any personal identifiers. They can complete the questionnaires at home. Participation in this study will last for 6 months.
Key facts
- Study ID
- NCT04721743
- Run by
- National Eye Institute (NEI)
- People needed
- 0
- Starts
- 2021-05-03
- Expected to finish
- 2021-05-03
- Last updated by the study team
- 2021-05-06
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- A participant is not eligible if any of the following exclusion criteria are present.
- Current acute diarrhea
- Current or recent (within one month) infectious gastroenteritis
- Current or recent use of systemic antibiotics (previous one month)
- History of partial gastrectomy or bariatric surgery
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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