Crohn DiseaseMICROSPANCT03983473
Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.
A study testing Microbiota Sequencing in people with Crohn Disease and Spondyloarthritis, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
The MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Spondyloarthritis
- What is being tested?
- Microbiota Sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Nov 2021to 16 Dec 2027
- 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
- Age ≥ 18 years.
- Patients will be recruited according to 3 groups:
- Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
- Patients with Crohn's disease (MC patients) with a diagnosis established according to clinical, biological criteria, radiological, endoscopic and / or histological studies for 3 months. With diagnosis of exclusion of a spondyloarthritis on criteria ASAS and / or New York modified.
- Patients with axial spondyloarthritis (SpA patients) with a diagnosis based on modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
- Patient with the ability to give free and express informed consent.
Who cannot join
- History of colonic resection
- Taking antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection (Temporary contraindication = removal possible before colic or first bowel preparation after the start of colonic preparation).
- Ostomy at the time of sampling
- BMI> 30
- extreme diet
- unbalanced diabetes
- Pregnant woman
- Patient under guardianship, under curatorship or under the protection of justice Contacts/Locations Central Contact
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Central Hospital
Nancy, Lorraine, 54500
Laurent MD PEYRIN-BIROULET, PhD
- Recruiting
Saint Antoine Hospital
Paris, 75012
Harry SOKOL, MD, PhD
Jérémie SELLAM, MD, PhD
About this study
Official title: Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. Identification de Biomarqueurs de SPondylArthrite Chez Les Patients Atteints de Maladie de CROhn présents Dans le MICrobiote fécal.
The MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing
- Conditions
- Crohn Disease, Spondyloarthritis
- Being tested
- Microbiota Sequencing
- Medical subject headings
- Crohn Disease, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota SequencingOther
virome, bacteriome, fungome NGS sequencing
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease | Other | Patients suffering from established Crohn 's disease without spondyloarthritis Receives: Other: Microbiota Sequencing |
| Spondyloarthritis | Other | Patients with established spondyloarthritis without Crohn 's disease Receives: Other: Microbiota Sequencing |
| Crohn + spondyloarthritis | Other | Patients suffering from both spondyloarthritis and Crohn 's disease Receives: Other: Microbiota Sequencing |
| Healthy controls | Other | Patients without spondyloarthritis and Crohn 's disease Receives: Other: Microbiota Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha and Beta diversity of Fecal bacteriome
Alpha (number of species) and Beta diversity (distribution of species)
Measured: + 6 months
Alpha and Beta diversity of Fecal fungome
Alpha (number of species) and Beta diversity (distribution of species)
Measured: + 6 months
Alpha and Beta diversity of Fecal virome
Alpha (number of species) and Beta diversity (distribution of species)
Measured: + 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start16 Nov 2021
- Primary completion4 Nov 2027 (estimated)
- Study completion16 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional Metz-Thionville, University Hospital, Strasbourg, France, Saint Antoine University Hospital
- Responsible party
- Principal investigator, FERRY Marine, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983473
- Sponsor's protocol ID
- 2020-A02298-31
- Acronym
- MICROSPA
- Status last verified
- Jun 2026
- First submitted
- 22 May 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. Identification de Biomarqueurs de SPondylArthrite Chez Les Patients Atteints de Maladie de CROhn présents Dans le MICrobiote fécal.
- ClinicalTrials.gov ID
- NCT03983473
- Acronym / sponsor ID
- MICROSPA / 2020-A02298-31
- Conditions
- Crohn Disease, Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional Metz-Thionville, University Hospital, Strasbourg, France, Saint Antoine University Hospital
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 4 Nov 2027 (estimated)
- Study completion
- 16 Dec 2027 (estimated)
- First posted
- 12 Jun 2019 (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 MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease | Other | Other: Microbiota SequencingPatients suffering from established Crohn 's disease without spondyloarthritis |
| Spondyloarthritis | Other | Other: Microbiota SequencingPatients with established spondyloarthritis without Crohn 's disease |
| Crohn + spondyloarthritis | Other | Other: Microbiota SequencingPatients suffering from both spondyloarthritis and Crohn 's disease |
| Healthy controls | Other | Other: Microbiota SequencingPatients without spondyloarthritis and Crohn 's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Patients will be recruited according to 3 groups:
- Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
- Patients with Crohn's disease (MC patients) with a diagnosis established according to clinical, biological criteria, radiological, endoscopic and / or histological studies for 3 months. With diagnosis of exclusion of a spondyloarthritis on criteria ASAS and / or New York modified.
- Patients with axial spondyloarthritis (SpA patients) with a diagnosis based on modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
Key exclusion criteria (8 listed)
- History of colonic resection
- Taking antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection (Temporary contraindication = removal possible before colic or first bowel preparation after the start of colonic preparation).
- Ostomy at the time of sampling
- BMI> 30
- extreme diet
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 |
|---|---|---|
| Microbiota Sequencingvirome, bacteriome, fungome NGS sequencing | Other | Crohn + spondyloarthritis, Crohn's disease, Healthy controls, Spondyloarthritis |
Primary outcome
Alpha and Beta diversity of Fecal bacteriome
Time frame: + 6 months
Alpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal fungome
Time frame: + 6 months
Alpha (number of species) and Beta diversity (distribution of species)
Alpha and Beta diversity of Fecal virome
Time frame: + 6 months
Alpha (number of species) and Beta diversity (distribution of species)
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 18 Jun 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiota Sequencing in people with Crohn Disease and Spondyloarthritis, run by Central Hospital, Nancy, France at 2 sites 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 6 inclusion and 8 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 Laurent MD PEYRIN-BIROULET, PhD (0383153661, peyrinbiroulet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha and Beta diversity of Fecal bacteriome (time frame: + 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.