Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT04713995
Status:
TERMINATED
Last Update Posted:
2022-07-08
First Post:
2020-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiome and Axial Spondyloarthritis
Sponsor:
Viome
Organization:
Study Overview
Official Title:
The Role of the Gut Microbiome in Axial Spondyloarthritis (AxSpA) Disease Activity
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sufficient samples and data have been collected for data analyses.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: