Microbiome as a ThErapeutic Response Biomarker

NCT04721743 | Withdrawn

• 2 other identifiers: 20007820-EI-0078
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Uveitis

Keywords

Uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Markers

  Study duration

Study Arms (1)

Affected Participants

Participants with Uveitis

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be uveitis participants enrolled as an ancillary study to the ADVISE trial.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Stool

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Hatice N Sen, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 25, 2021
• Study Start: May 3, 2021
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

US (1)