SpondyloarthritisRUMINOSPANCT04853212
The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis
A study testing Biopsy in people with Spondyloarthritis and Ruminococcus Gnavus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spondyloarthritis, Ruminococcus Gnavus
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2021to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with SPA:
- Patients ⩾ 18 years;
- Diagnosed as spondyloarthritis (SpA) according ASAS classification;
- Affiliated to a social security scheme;
- Have signed the written informed consent form.
- Control subjects:
Show all 10Show fewer
- Subjects ⩾ 18 years;
- Subjects free of SPA and planned for a digestive endoscopy for another indication such as to explore the risk of colorectal cancer in family member;
- Affiliated to a social security scheme;
- Have signed the written informed consent form.
Who cannot join
- Subjects unable to understand the proposed study and/or sign a informed consent form;
- Pregnant women or breast feeding women;
- Subjects under guardianship or curatorship;
- Have taken antibiotic 1 month prior to inclusion;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Rhumatologie, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, 92100
About this study
Official title: The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis
The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).
Read the detailed description
As secondary objectives, the study aims:
- to research the abundance of bacterial strain of R. gnavus in mucosal sampling by biopsy;
- to study the interaction between R. gnavus bacterium and mucus from histological sampling;
- to correlate the expression of genes of intestinal mucus with the variations of identified microbiota of mucus biopsy;
- to study the interaction between bacteria and intestinal epithelial cells during culture;
- to demonstrate perturbations of the immune responses by dysbiosis.
- Conditions
- Spondyloarthritis, Ruminococcus Gnavus
- Being tested
- Biopsy
- Keywords
- Spondyloarthritis, Ruminococcus gnavus, Microbiota, Dysbiosis
- Medical subject headings
- Spondylarthritis, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Biopsy during recto-coloscopy
| Study group | Role | What they receive |
|---|---|---|
| SPA patient | Active comparator | Patients with SPA Receives: Procedure: Biopsy |
| Subject without SPA | Sham comparator | Health subjects without SPA, planned to undergo a digestive endoscopy. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation and characterization of R. gnavus
Isolation and characterization of R. gnavus bacterium from intestinal biopsy.
Measured: At the end of study, up to 2 years
Bacteria analysis
Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.
Measured: At the end of study, up to 2 years
Secondary outcomes (5)
Bacterial strain's abundance
Compare the abundance by RT-q-PCR of bacterial strain (R. gnavus) between mucus biopsy sampling and faecal sampling, collected from PCR patients or control subjects respectively.
Measured: At the end of study, up to 2 years
Mucin-degradation of Ruminococcus gnavus
Study the ability of the strain to grow on mucins of intestinal biopsy, colored after fixation to carnoy.
Measured: At the end of study, up to 2 years
RNA sequencing analysis of biopsy
RNA sequencing analysis of rectal biopsy between SPA patients and control subjects.
Measured: At the end of study, up to 2 years
Interaction between bacteria and intestinal epithelial cells
In order to study the interaction between bacteria and intestinal epithelial cells in culture (organoids).
Study the induction of several target genes as peptides anti-microbians, mucin or chemokines by RT-q-PCR.
Measured: At the end of study, up to 2 years
Dysbiosis-induced immune perturbations
To compare between 2 groups their reactivities of T cells from intestinal biopsy which contact with cells of exposed antigens in vitro, to R. gnavus stains or to other stains biopsied from control subjects.
Measured: At the end of study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start14 Jun 2021
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime BREBAN, MD, PhD, Principal investigator, Service de Rhumatologie, Hôpital Ambroise Paré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853212
- Sponsor's protocol ID
- APHP210332
- Other IDs
- 2020-A03244-35
- Acronym
- RUMINOSPA
- Status last verified
- Mar 2025
- First submitted
- 16 Apr 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28606969Crost EH, Tailford LE, Monestier M, Swarbreck D, Henrissat B, Crossman LC, Juge N. The mucin-degradation strategy of Ruminococcus gnavus: The importance of intramolecular trans-sialidases. Gut Microbes. 2016 Jul 3;7(4):302-312. doi: 10.1080/19490976.2016.1186334. Epub 2016 May 25.
PubMed 27223845
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis
- ClinicalTrials.gov ID
- NCT04853212
- Acronym / sponsor ID
- RUMINOSPA / APHP210332
- Conditions
- Spondyloarthritis, Ruminococcus Gnavus
- Keywords
- Spondyloarthritis, Ruminococcus gnavus, Microbiota, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).
Detailed description
As secondary objectives, the study aims:
- to research the abundance of bacterial strain of R. gnavus in mucosal sampling by biopsy;
- to study the interaction between R. gnavus bacterium and mucus from histological sampling;
- to correlate the expression of genes of intestinal mucus with the variations of identified microbiota of mucus biopsy;
- to study the interaction between bacteria and intestinal epithelial cells during culture;
- to demonstrate perturbations of the immune responses by dysbiosis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPA patient | Active comparator | Procedure: BiopsyPatients with SPA |
| Subject without SPA | Sham comparator | Procedure: BiopsyHealth subjects without SPA, planned to undergo a digestive endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients ⩾ 18 years;
- Diagnosed as spondyloarthritis (SpA) according ASAS classification;
- Affiliated to a social security scheme;
- Have signed the written informed consent form.
- Subjects ⩾ 18 years;
Key exclusion criteria (7 listed)
- Subjects unable to understand the proposed study and/or sign a informed consent form;
- Pregnant women or breast feeding women;
- Subjects under guardianship or curatorship;
- Have taken antibiotic 1 month prior to inclusion;
- Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyBiopsy during recto-coloscopy | Procedure or surgery | SPA patient, Subject without SPA |
Primary outcome
Isolation and characterization of R. gnavus
Time frame: At the end of study, up to 2 years
Isolation and characterization of R. gnavus bacterium from intestinal biopsy.
Bacteria analysis
Time frame: At the end of study, up to 2 years
Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.
5 secondary outcomes
Bacterial strain's abundance
Time frame: At the end of study, up to 2 years
Mucin-degradation of Ruminococcus gnavus
Time frame: At the end of study, up to 2 years
RNA sequencing analysis of biopsy
Time frame: At the end of study, up to 2 years
Interaction between bacteria and intestinal epithelial cells
Time frame: At the end of study, up to 2 years
Dysbiosis-induced immune perturbations
Time frame: At the end of study, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 28606969Breban 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.
- Background: PubMed 27223845Crost EH, Tailford LE, Monestier M, Swarbreck D, Henrissat B, Crossman LC, Juge N. The mucin-degradation strategy of Ruminococcus gnavus: The importance of intramolecular trans-sialidases. Gut Microbes. 2016 Jul 3;7(4):302-312. doi: 10.1080/19490976.2016.1186334. Epub 2016 May 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maxime BREBAN, MD, PhD principal investigator
Service de Rhumatologie, Hôpital Ambroise Paré, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Spondyloarthritis and Ruminococcus Gnavus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime BREBAN, MD, PhD (+33 1 49 09 56 72, maxime.breban@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation and characterization of R. gnavus (time frame: At the end of study, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853212, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.