UveitisNCT04721743
Microbiome as a ThErapeutic Response Biomarker
An observational study of Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Uveitis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 3 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be uveitis participants enrolled as an ancillary study to the ADVISE trial.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read 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 segment uveitis patients.
Study Population: Up to 150 participants with uveitis may be enrolled in this study across up to 21 participating sites.
Design: This is a prospective, case-control ancillary study. Participants will be asked to provide a stool sample, blood sample, and complete an on-line Diet History Questionnaire (DHQ). The study will last approximately three years, with two years for recruitment and one year for follow-up. Participants must be co-enrolled in the parent ADVISE protocol (NCT 03828019.) in order to be eligible for this study.
Outcome Measures: The primary outcome answers whether there is a gut microbial signature at baseline that can predict therapeutic response among uveitis patients. Additionally, this study will explore whether the gut microbial ecology change differentially in response to conventional immunosuppressives or tumor necrosis factor inhibitors (TNFi) treatment. Secondary outcomes include exploring if there are molecular or immune phenotypic markers of activity or therapeutic response: To identify molecular correlates of disease activity and treatment response through transcriptional profiling (bulk ribonucleic acid (RNA) sequencing of whole blood samples collected in PAXgene tubes or a similar RNA stabilizing tube) and to identify immunophenotypic correlates of activity and treatment response through flow cytometry analysis (using Transfix tubes or a similar direct draw collection tubes used to stabilize venous blood at the point of collection and preserve whole blood specimens for immunophenotyping by flow cytometry.)
- Conditions
- Uveitis
- Keywords
- Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected Participants | Participants with Uveitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study duration
Secondary outcomes (1)
Markers
Explore if there are molecular or immune phenotypic markers of activity or therapeutic response.
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start3 May 2021
- Primary completion3 May 2021
- Study completion3 May 2021
Why it stopped: No participants were enrolled. Investigator left NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hatice N Sen, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721743
- Sponsor's protocol ID
- 200078
- Other IDs
- 20-EI-0078
- Status last verified
- May 2021
- First submitted
- 22 Jan 2021
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome as a ThErapeutic Response Biomarker
- ClinicalTrials.gov ID
- NCT04721743
- Acronym / sponsor ID
- 200078
- Conditions
- Uveitis
- Keywords
- Uveitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled. Investigator left NIH.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 3 May 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 segment uveitis patients.
Study Population: Up to 150 participants with uveitis may be enrolled in this study across up to 21 participating sites.
Design: This is a prospective, case-control ancillary study. Participants will be asked to provide a stool sample, blood sample, and complete an on-line Diet History Questionnaire (DHQ). The study will last approximately three years, with two years for recruitment and one year for follow-up. Participants must be co-enrolled in the parent ADVISE protocol (NCT 03828019.) in order to be eligible for this study.
Outcome Measures: The primary outcome answers whether there is a gut microbial signature at baseline that can predict therapeutic response among uveitis patients. Additionally, this study will explore whether the gut microbial ecology change differentially in response to conventional immunosuppressives or tumor necrosis factor inhibitors (TNFi) treatment. Secondary outcomes include exploring if there are molecular or immune phenotypic markers of activity or therapeutic response: To identify molecular correlates of disease activity and treatment response through transcriptional profiling (bulk ribonucleic acid (RNA) sequencing of whole blood samples collected in PAXgene tubes or a similar RNA stabilizing tube) and to identify immunophenotypic correlates of activity and treatment response through flow cytometry analysis (using Transfix tubes or a similar direct draw collection tubes used to stabilize venous blood at the point of collection and preserve whole blood specimens for immunophenotyping by flow cytometry.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Affected Participants | – | –Participants with Uveitis |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be uveitis participants enrolled as an ancillary study to the ADVISE trial.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome measurement
Time frame: Study duration
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.
1 secondary outcome
Markers
Time frame: Study duration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice N Sen, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome measurement (time frame: Study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.