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NCT04713995 · ClinicalTrials.gov registry record · NA

Microbiome and Axial Spondyloarthritis

A NA study, sponsored by Viome.

Terminated
Registry status
NA
Development phase
95
Enrollment target

NCT04713995: Clinical Trial NA study, sponsored by Viome.

NCT04713995 is a NA study that was terminated before completion, run by Viome. The registered enrollment target is 95 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04713995, a NA study, was terminated before completion, sponsored by Viome.

TERMINATED
Registry status
NA
Development phase
95 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • OTHER Dietary recommendations

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2020-06-22
Est. Completion 2022-06-15
Phase NA
Viome

18 total trials

Why NCT04713995 stopped before completion

NCT04713995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Dietary recommendations is the first listed.

NCT04713995 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04713995 about?

NCT04713995 is a clinical study titled "Microbiome and Axial Spondyloarthritis". 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 m...

What is the current status of trial NCT04713995?

This trial is currently terminated. It is a NA study. The enrollment target is 95 participants. The study started on 2020-06-22. Estimated completion is 2022-06-15.

What interventions are being tested in trial NCT04713995?

The interventions under investigation include: Dietary recommendations (OTHER).

Who is sponsoring clinical trial NCT04713995?

This trial is sponsored by Viome, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04713995's enrollment target sits among peer trials

95 931st of 2000 higher than 1,066 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04713995, the US trial registry maintained by the National Library of Medicine. NCT04713995 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.