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RecruitingNCT04292067MICROBIARTUpdated Jun 15, 2025

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

An observational study in Spondyloarthritis and Rheumatoid Arthritis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Started Nov 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Spondylarthritis by Assistance Publique - Hôpitaux de Paris — 5 open to participants now, 5 under way, none of them phase 3. Spondylarthritis · Assistance Publique - Hôpitaux de Paris.

Started
2020
with 2 others
Observational
9 of 14
3 open now
Registered
6th of 14
by date

Among the 14 studies in Spondylarthritis by Assistance Publique - Hôpitaux de Paris, this one is one of 3 that started in 2020, is one of 9 observational ones, and was the 6th registered.

By phase

14 studies; the count open now beside each. This study's row is marked.

Observationalthis study9 · 3 open
No phase5 · 2 open

By the year they started

First in 2005; this study’s year is marked. 3 started in 2020.

What they test

Methotrexate1

Size and results

Median enrollment 129 across the 5 interventional studies, 300 across the 9 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 14 studies in Spondylarthritis by Assistance Publique - Hôpitaux de Paris, or all of them as a file.
02

Study summary

The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.

Read the detailed description

As secondary objectives, the study aims to analyse the relation between different clinical parameters such as age, gender, duration of the disease, or the nature of ongoing treatment, and the the composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in SPA and/or RA. Analyse the relation between metabolome of faecale and plasma and the composition of intestinal microbiota.

This study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.

03

Conditions studied

  • Spondyloarthritis
  • Rheumatoid Arthritis

Keywords

  • Spondyloarthritis
  • Rheumatoid Arthritis
  • Microbiota
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  • Adult patient diagnosed spondyloarthritis or rheumatoid polyarthritis;
  • Healthy adult subjects free of chronic pathology.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients:

  • Patient ⩾ 18 years;
  • Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR/EULAR;
  • Affiliated to a social security scheme;
  • Have signed the written form.

Healthy control subjects:

  • Adult women and men;
  • Subjet free of chronic pathology;
  • Affiliated to a social security scheme;
  • Have signed the written informed consent form.

Exclusion criteria

Exclusion Criteria:

Patients:

  • Patients unable to understand the proposed study and/or sign a form;
  • Pregnant women or breast feeding women;
  • Patient ⩾ 18 years;
  • Patients under guardianship or curatorship;
  • Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;
  • Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
  • Foreign patients under french AME scheme;
  • Patients had have participated in the prior study Microbiart.

Healthy control subjects:

  • Subjects unable to understand the proposed study and/or sign a informed consent form;
  • Pregnant women or breast feeding women;
  • Subjects \< 18 years;
  • Subjects under guardianship or curatorship;
  • Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
  • Refusal of subjects to participate to the study;
  • Foreign patients under french AME scheme;
  • Subjects had have participated in the prior study Microbiart.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • patients with SPA

    100 SPA patients

    Biological: Faecal sampling · Biological: Blood sampling

  • Healthy subjets

    200 healthy subjets in control group

    Biological: Faecal sampling · Biological: Blood sampling

  • patients with RA

    100 RA patients

    Biological: Faecal sampling · Biological: Blood sampling

Interventions

  • BiologicalFaecal sampling

    Faecal sampling at baseline

  • BiologicalBlood sampling

    Blood sampling at baseline

06

What researchers measure

Primary outcomes

  1. Bacteria analysis

    Quantitative analysis of repartition of bacteria in each group and the comparison between groups.

    Time frame: At the end of study, up to 4 years

Secondary outcomes

  1. Intestinal microbiota composition

    Intestinal microbiota composition will be analysed

    Time frame: At the end of study, up to 4 years

07

Study locations

1 of 1 sites recruiting
  • Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
    Boulogne-Billancourt, 92100, France
    Recruiting
08

References and documents

Publications

  • Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12. PubMed 28606969 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2020 (actual). Primary completion is estimated for Nov 2026, 72 months after the start.

Of 50 observational studies under Spondylarthritis, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 201. This study's planned 72 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2020
First posted
Mar 2, 2020
StartActual
Nov 23, 2020
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Jun 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04292067
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Mar 2, 2020
Start date
Nov 23, 2020
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jun 15, 2025

Study contacts

Maxime BREBAN, MD, PhD
Contact
maxime.breban@aphp.fr
+ 33 1 49 09 56 72
Maxime BREBAN, MD, PhD
principal investigator · Service de Rhumatologie, Hôpital Ambroise Paré, APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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