Status:
TERMINATED
Microbiome and Axial Spondyloarthritis
Lead Sponsor:
Viome
Collaborating Sponsors:
Spondylitis Association of America (SAA)
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04713995
Start Date
June 22 2020
End Date
June 15 2022
Last Update
July 8 2022
Active Locations (1)
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1
Viome Research Institute online: https://www.viome.com/VRI/studies
Bothell, Washington, United States, 98011