Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Inflammatory Bowel Diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic, disabling conditions affecting young adults, marked by flare-ups and remissions. Traditionally, IBD was treated with immunosuppressants like thiopurines, but new biological treatments, such as anti-TNFa antibodies (e.g., infliximab, adalimumab), have transformed management. Biologics often combine with thiopurines but come with risks, like increased chances of skin cancers and lymphomas, especially for prolonged use in young patients. Recently, newer biologics (e.g., ustekinumab, vedolizumab) and small molecules like JAK inhibitors have expanded treatment options.

The exact cause of IBD remains unknown, though an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals is suspected. Dysbiosis, or imbalance in gut microbiota, has been linked to IBD, with reductions in 'beneficial' bacteria and increases in harmful ones. Certain bacteria, like Faecalibacterium prausnitzii, may serve as markers for disease activity or progression.

Due to the heterogeneity of UC and CD, it is crucial to identify early predictive factors for complications and treatment response. This study aims to identify biological markers of disease course and complications in IBD and to deepen understanding of its pathophysiological mechanisms.

Eligibility criteria

Qualifiers

Person able to give free and informed consent.

Age ≥ 18 years.

Beneficiary of a social protection scheme or entitled person (excluding AME).

Consultation in the Gastroenterology and Nutrition Department of Saint-Antoine Hospital

Disqualifiers

Subjects under guardianship, curatorship or safeguard of justice.

Subjects who do not speak French.

Subject suffering from a chronic disease

Antibiotics taken in the 6 weeks prior to endoscopy

Trial design

Treatments tested in this trial

  • Blood, fecal, saliva
  • intestinal content samples and biopsies

Treatment groups

4,500 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators