Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Cro… (NCT03983473) | Clinical Trial Compass
RecruitingNot Applicable
Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.
France240 participantsStarted 2021-11-16
Plain-language 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. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at bacteria, fungi, and viruses in stool samples from people who have both Crohn's disease and spondyloarthritis — does my specific situation fit what they're looking for, and is this something worth discussing with my care team?
2Since this study is purely observational and focused on identifying biomarkers rather than testing a treatment, what would I actually need to do as a participant, and would providing stool samples or other data affect my current Crohn's disease care in any way?
3Could participating in this kind of microbiome research give me or my doctors any useful information about my own condition, or is the data collected only used for the broader research study?
4Given that this study is looking at the overlap between Crohn's disease and spondyloarthritis, should I be evaluated for spondyloarthritis if I haven't been already, and how does that affect whether this trial might be relevant to me?
5Are there other studies or clinical options focused on actually treating the combination of Crohn's disease and spondyloarthritis that might be worth exploring alongside or instead of a biomarker identification study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.