Microbiome and Axial Spondyloarthritis

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    400
  • sponsor
    Viome
Updated on 14 May 2022
Accepts healthy volunteers

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). 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.

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.

Details
Condition Axial Spondyloarthritis
Treatment Dietary recommendations, Nutritional Recommendations
Clinical Study IdentifierNCT04713995
SponsorViome
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

How to participate?

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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