Status:
WITHDRAWN
Microbiome as a ThErapeutic Response Biomarker
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Uveitis
Eligibility:
All Genders
13+ years
Brief Summary
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 ...
Detailed Description
Objective: To investigate the potential of gut microbiota as a biomarker of responsiveness to treatment and to evaluate treatment related changes in fecal microbiota composition among posterior segmen...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible, the following inclusion criteria must be met, where applicable.
- Participant has uveitis and is being enrolled in ADVISE parent clinical trial (NCT 03828019)
- 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)
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
May 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 3 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04721743
Start Date
May 3 2021
End Date
May 3 2021
Last Update
May 6 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892