Axial SpondyloarthritisNCT04713995
Microbiome and Axial Spondyloarthritis
A study testing Dietary recommendations in people with Axial Spondyloarthritis, run by Viome at 1 site in United States.
Trial summary
The purpose of this interventional study is to identify the root cause(s) of AxSpA (Axial Spondyloarthritis) relapses, which are likely due to the combination of nutrition, gut microbiome activities, leaky gut, and human genes (particularly from the immune system). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Dietary recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 15 Jun 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ICD-10 disease code or diagnosis for AxSpA
- Confirmed diagnosis of AxSpA, based on ASDAS criteria including both non-radiographic axial spondyloarthritis and ankylosing spondylitis
- HLA-B27 positive
- Signed informed consent prior to any study-specific procedures are performed
- Females and males aged 18 years or older
- Able to read, speak and understand English
Show all 10Show fewer
- Willing and able to use the at-home collection kits and mail in pre-paid mailers
- Willing and able to use a smartphone app or web app to answer surveys
- Willing and able to make and keep/travel to a local lab visit for blood collection
- Willing and able to follow the study instructions, as described in the recruitment letter
Who cannot join
- Unable or unwilling to use Viome's App on an iPhone or Android smartphone
- Not HLA-B27 positive
- No diagnosis for AxSpA/AS
- Pregnant or nursing
- Other diagnosis of arthritis (rheumatoid, osteoarthritis, psoriatic arthritis, psoriatic spondyloarthritis)
- IBD/Crohn's disease/ulcerative colitis
- Use of antibiotics or Sulfasalazine within the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Viome Research Institute online: https://www.viome.com/VRI/studies
Bothell, Washington, 98011
About this study
Official title: The Role of the Gut Microbiome in Axial Spondyloarthritis (AxSpA) Disease Activity
The purpose of this interventional study is to identify the root cause(s) of AxSpA (Axial Spondyloarthritis) relapses, which are likely due to the combination of nutrition, gut microbiome activities, leaky gut, and human genes (particularly from the immune system). This will be done by identifying molecular features of the microbiome that are associated with AxSpA flares, progression and relapses.
The study will recruit participants with confirmed AxSpA diagnosis and who are HLA-B27 positive. During screening potential participants allow access to medical records to confirm eligibility requirements, such as diagnosis. Once enrolled, collection kits are sent to participants to collect samples using at-home collection kits and then provide a fasting blood sample at a local lab. Samples are then analyzed to identify features that likely cause AxSpA issues. Survey's are also answered to collect additional health data. Scientists will then use the data to identify the features that likely cause AxSpA flares and relapses.
Read the detailed description
This is an Interventional study to help find the root causes of AxSpA relapses, flares and progression. The study will enroll 400 participants who are aged 18 or over, are HLA-B27 positive, have had a diagnosis of AxSpA. An informed consent form is acknowledged and medical release signed (to confirm eligibility criteria). Participants sign up online and answer questions about their physical and mental health and how they are doing (through an app and/or website). The participants will be in the study approximately 3 months, unless they agree to complete the 3 and 6 month timeline assessments for the longitudinal timelines, then the study will be completed after those timelines.
If eligible, participants are shipped at-home collection kits which include: saliva, finger-prick blood and stool. A Genova urine test is also included to check intestinal permeability. Participants also make an appointment and go to a local lab to collect an additional blood sample. All samples are shipped via pre-paid mailers. All collections are done within a 1-week window (or 7 days). Clinical samples are collected in order to analyze specific molecular features associated with AxSpA in the microbiome found in participants.
After shipping home collection kits and visiting the lab for a blood draw, participants receive diet recommendations which they will follow for ~3 months, after which time they will fill out a study survey to complete the first timeline in the study.
If interested in participating in the longitudinal portion of the study, participants can also complete the 3-month and 6-month home collection, blood collection at the local lab and additional surveys.
Scientists hope to find the microbiome and molecular information that corresponds to flares, health and wellness in the microbiome in patients with AxSpA.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Dietary recommendations
- Keywords
- AxSpA, Microbiome, Viome, ASDAS, AS, Spondyloarthritis, HbA1c, Ankylosing, HLA B27, Spine, Ankylosing Spondylitis
- Medical subject headings
- Axial Spondyloarthritis, Spondylarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary recommendationsOther
Dietary recommendations based on microbiome analysis of samples will be given and expected to receive and report in ~3 months survey after following recommendations.
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Other | Enrolled with: AxSpA diagnosis, HLA-B27 positive, mASDAS > or = 1.3 and HLA-B27 positive. Will complete surveys online or on an app, about mental and physical health and how they are doing, submits and collection of samples (blood, stool, saliva, urine, fasting blood test at local lab). Receives results of some of the analysis of samples. Participants that qualify and complete the first set of samples can be eligible for the 3 and 6 month longitudinal follow-up collection kits.
All participants receive dietary recommendations based on samples collected and the analysis of the microbiome. Receives: Other: Dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
AxSpA (Axial Spondyloarthritis) disease activity
Analysis using lab results and AI learning models to correspond microbiome activity will be used to see if nutrition affects disease activity of the microbiome of people with AxSpA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start22 Jun 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Why it stopped: Sufficient samples and data have been collected for data analyses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by ViomeThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 400 Participants are enrolled and paired matching for HLA-B27+ and control (mASDAS \<1.3) and case group (mASDAS = or \> 1.3) and compared to a healthy control group. Samples and surveys are collected from all participants. Then again at 3 months and 6 months if they agree to complete the longitudinal arms of the study.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spondylitis Association of America (SAA)
- Responsible party
- Sponsor
- Investigators
- Momochilo Vuyisich, PhD, Principal investigator, Viome Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713995
- Sponsor's protocol ID
- V150
- Status last verified
- Jul 2022
- First submitted
- 31 Aug 2020
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Gut Microbiome in Axial Spondyloarthritis (AxSpA) Disease Activity
- ClinicalTrials.gov ID
- NCT04713995
- Acronym / sponsor ID
- V150
- Conditions
- Axial Spondyloarthritis
- Keywords
- AxSpA, Microbiome, Viome, ASDAS, AS, Spondyloarthritis, HbA1c, Ankylosing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sufficient samples and data have been collected for data analyses.
- Enrolment
- 95 participants (actual)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Collaborators
- Spondylitis Association of America (SAA)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 19 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.
The purpose of this interventional study is to identify the root cause(s) of AxSpA (Axial Spondyloarthritis) relapses, which are likely due to the combination of nutrition, gut microbiome activities, leaky gut, and human genes (particularly from the immune system). This will be done by identifying molecular features of the microbiome that are associated with AxSpA flares, progression and relapses.
The study will recruit participants with confirmed AxSpA diagnosis and who are HLA-B27 positive. During screening potential participants allow access to medical records to confirm eligibility requirements, such as diagnosis. Once enrolled, collection kits are sent to participants to collect samples using at-home collection kits and then provide a fasting blood sample at a local lab. Samples are then analyzed to identify features that likely cause AxSpA issues. Survey's are also answered to collect additional health data. Scientists will then use the data to identify the features that likely cause AxSpA flares and relapses.
Detailed description
This is an Interventional study to help find the root causes of AxSpA relapses, flares and progression. The study will enroll 400 participants who are aged 18 or over, are HLA-B27 positive, have had a diagnosis of AxSpA. An informed consent form is acknowledged and medical release signed (to confirm eligibility criteria). Participants sign up online and answer questions about their physical and mental health and how they are doing (through an app and/or website). The participants will be in the study approximately 3 months, unless they agree to complete the 3 and 6 month timeline assessments for the longitudinal timelines, then the study will be completed after those timelines.
If eligible, participants are shipped at-home collection kits which include: saliva, finger-prick blood and stool. A Genova urine test is also included to check intestinal permeability. Participants also make an appointment and go to a local lab to collect an additional blood sample. All samples are shipped via pre-paid mailers. All collections are done within a 1-week window (or 7 days). Clinical samples are collected in order to analyze specific molecular features associated with AxSpA in the microbiome found in participants.
After shipping home collection kits and visiting the lab for a blood draw, participants receive diet recommendations which they will follow for ~3 months, after which time they will fill out a study survey to complete the first timeline in the study.
If interested in participating in the longitudinal portion of the study, participants can also complete the 3-month and 6-month home collection, blood collection at the local lab and additional surveys.
Scientists hope to find the microbiome and molecular information that corresponds to flares, health and wellness in the microbiome in patients with AxSpA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 400 Participants are enrolled and paired matching for HLA-B27+ and control (mASDAS <1.3) and case group (mASDAS = or > 1.3) and compared to a healthy control group. Samples and surveys are collected from all participants. Then again at 3 months and 6 months if they agree to complete the longitudinal arms of the study.
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | Other | Other: Dietary recommendationsEnrolled with: AxSpA diagnosis, HLA-B27 positive, mASDAS > or = 1.3 and HLA-B27 positive. Will complete surveys online or on an app, about mental and physical health and how they are doing, submits and collection of samples (blood, stool, saliva, urine, fasting blood test at local lab). Receives results of some of the analysis of samples. Participants that qualify and complete the first set of samples can be eligible for the 3 and 6 month longitudinal follow-up collection kits. All participants receive dietary recommendations based on samples collected and the analysis of the microbiome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ICD-10 disease code or diagnosis for AxSpA
- Confirmed diagnosis of AxSpA, based on ASDAS criteria including both non-radiographic axial spondyloarthritis and ankylosing spondylitis
- HLA-B27 positive
- Signed informed consent prior to any study-specific procedures are performed
- Females and males aged 18 years or older
Key exclusion criteria (7 listed)
- Unable or unwilling to use Viome's App on an iPhone or Android smartphone
- Not HLA-B27 positive
- No diagnosis for AxSpA/AS
- Pregnant or nursing
- Other diagnosis of arthritis (rheumatoid, osteoarthritis, psoriatic arthritis, psoriatic spondyloarthritis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary recommendationsDietary recommendations based on microbiome analysis of samples will be given and expected to receive and report in ~3 months survey after following recommendations. | Other | All Study Participants |
Primary outcome
AxSpA (Axial Spondyloarthritis) disease activity
Time frame: 1 year
Analysis using lab results and AI learning models to correspond microbiome activity will be used to see if nutrition affects disease activity of the microbiome of people with AxSpA
Results and safety
The study was stopped early (reason given: Sufficient samples and data have been collected for data analyses.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Momochilo Vuyisich, PhD principal investigator
Viome Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary recommendations in people with Axial Spondyloarthritis, run by Viome 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 10 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 Jul 2022. 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 stopped early (reason given: Sufficient samples and data have been collected for data analyses.). Results are not available in the source record.
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?
AxSpA (Axial Spondyloarthritis) disease activity (time frame: 1 year). 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 8 Jul 2022.