Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.
Not applicable · Testing Microbiota Sequencing · 2 sites · Central Hospital, Nancy, France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Microbiota Sequencing as a screening approach. Condition(s) listed: Crohn Disease and Spondyloarthritis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Age ≥ 18 years.
- Patients will be recruited according to 3 groups:
- Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
Plus 3 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 240 participants are expected to take part.
- Start date: 2021-11-16.
- Main results expected around 2027-11-04 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in France.
Main thing being measured
- Alpha and Beta diversity of Fecal bacteriome (+ 6 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Spondyloarthritis |
| Lead sponsor | Central Hospital, Nancy, France |
| Collaborators | Centre Hospitalier Régional Metz-Thionville; University Hospital, Strasbourg, France; Saint Antoine University Hospital |
| Enrollment | 240 (estimated) |
| Start date | 2021-11-16 |
| Primary completion (est.) | 2027-11-04 |
| First posted | 2019-06-12 |
| Last updated | 2026-06-18 |
| 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 |
Interventions
- Microbiota Sequencing (Other)
virome, bacteriome, fungome NGS sequencing
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Antoine Hospital | Paris | France | Recruiting |
| Central Hospital | Nancy, Lorraine | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.