Microbiome and Axial Spondyloarthritis

NCT04713995 | Terminated

• 1 other identifier: V150
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Axial Spondyloarthritis

Keywords

AxSpA; Microbiome; Viome; ASDAS; AS; Spondyloarthritis; HbA1c; Ankylosing; HLA B27; Spine; Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (1)

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.

Other: Dietary recommendations

Interventions

Dietary recommendations OTHER

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

All Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viome: lead
• Spondylitis Association of America (SAA): collaborator

Study Sites (1)

Viome Research Institute online: https://www.viome.com/VRI/studies

Bothell, Washington, 98011, United States

Location

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylarthritis; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Momochilo Vuyisich, PhD

  Viome Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All recruitment happens online. All nutritional recommendations look the same, but may be different between participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: January 19, 2021
• Study Start: June 22, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)