Microbiome and Axial Spondyloarthritis

July 5, 2022 updated by: Viome

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Bothell, Washington, United States, 98011
        • Viome Research Institute online: https://www.viome.com/VRI/studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All Study Participants

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.
Other: Dietary recommendations
Dietary recommendations based on microbiome analysis of samples will be given and expected to receive and report in ~3 months survey after following recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viome

Collaborators

Spondylitis Association of America (SAA)

Investigators

  • Principal Investigator: Momochilo Vuyisich, PhD, Viome Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Axial Spondyloarthritis

Clinical Trials on Dietary recommendations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe