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NCT03983473Recruiting

Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.

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.

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
22 May 2019
Start date
16 Nov 2021
Primary completion date
4 Nov 2027
Lead sponsor
Central Hospital, Nancy, France
NCT number
NCT03983473

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 16 Nov 2021 to the primary completion date, 4 Nov 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • History of colonic resection
  • unbalanced diabetes

Other

  • Ostomy at the time of sampling
  • BMI\> 30
  • extreme diet
  • Pregnant woman
  • Patient under guardianship, under curatorship or under the protection of justice Contacts/Locations Central Contact

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Central Hospital
Coordinator of this site? Confirm its status
NancyFranceRecruiting
Saint-Antoine Hospital
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.