Uveitis Clinical Trial
Official title:
Microbiome as a ThErapeutic Response Biomarker
NCT number | NCT04721743 |
Other study ID # | 200078 |
Secondary ID | 20-EI-0078 |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | May 3, 2021 |
Est. completion date | May 3, 2021 |
Verified date | May 2021 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 3, 2021 |
Est. primary completion date | May 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility | - INCLUSION CRITERIA: To be eligible, the following inclusion criteria must be met, where applicable. 1. Participant has uveitis and is being enrolled in ADVISE parent clinical trial (NCT 03828019) 2. Participant is willing to provide fecal and blood samples at predetermined time points (two time points that coincide with the clinical trial related blood draws) 3. Participant willing to fill the online health and dietary (food frequency) questionnaire (DHQIII) EXCLUSION CRITERIA: A participant is not eligible if any of the following exclusion criteria are present. 1. Current acute diarrhea 2. Current or recent (within one month) infectious gastroenteritis 3. Current or recent use of systemic antibiotics (previous one month) 4. History of partial gastrectomy or bariatric surgery |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gut microbiome measurement | Answers whether there is a gut microbiome signature at baseline that can predict therapeutic response among uveitis patients and explore whether the gut microbial ecology changes differentially in response to conventional immunosuppressives or tumor necrosis factor inhibitors treatment. | Study duration | |
Secondary | Markers | Explore if there are molecular or immune phenotypic markers of activity or therapeutic response. | Study duration |
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