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Microbiome and Axial Spondyloarthritis

NCT04713995 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2022-07-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Spondylitis Association of America (SAA)

    collaborator UNKNOWN

  • Viome

    lead INDUSTRY

Principal Investigators

  • Momochilo Vuyisich, PhD · Viome Research Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2022-06-15
Completion
2022-06-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713995 on ClinicalTrials.gov