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

NCT07172945 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4500

Last updated 2025-09-15

No results posted yet for this study

Summary

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.

Conditions

  • Crohn
  • Ulcerative Colitis (UC)
  • IBD (Inflammatory Bowel Disease)

Interventions

OTHER

Blood, fecal, saliva

Blood, fecal and saliva samples

OTHER

intestinal content samples and biopsies

intestinal content samples and biopsies obtained per upper or lower gastrointestinal tract endoscopy

Sponsors & Collaborators

  • Sorbonne University

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Harry SOKOL, Professor · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2040-11-30
Completion
2040-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172945 on ClinicalTrials.gov