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

NCT07172945 | Not Yet Recruiting

• 2 other identifiers: APHP240151IDRCB: 2024-A00348-39
• Study Type: interventional
• Target: 4,500
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Microbiome; Biobank; Crohn; Ulcerative colitis; IBD

Outcome Measures

Primary Outcomes (1)

• Relation between biological parameters (fecal and ileal microbiome) and outcomes of IBD

  identify relations between fecal and ileal microbiome and disease evolution

  up to 12 months after the inclusion

Study Arms (3)

Patients with Inflammatory Bowel Diseases

OTHER

Other: Blood, fecal, saliva; Other: intestinal content samples and biopsies

Microbiota control' subjects

OTHER

Other: Blood, fecal, saliva

Endoscopy control' subjects

OTHER

Other: Blood, fecal, saliva; Other: intestinal content samples and biopsies

Interventions

Blood, fecal, saliva OTHER

Blood, fecal and saliva samples

Endoscopy control' subjects; Microbiota control' subjects; Patients with Inflammatory Bowel Diseases

intestinal content samples and biopsies OTHER

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

Endoscopy control' subjects; Patients with Inflammatory Bowel Diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all patients and control subjects
• 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
• Patients with IBD :
• \- Patients with Crohn's disease or haemorrhagic rectocolitis with a diagnosis established or confirmed in the Gastroenterology and Nutrition Department at Saint-Antoine Hospital.
• Microbiota control' subjects:
• \- Healthy subjects seen in consultation as a preventive measure or as part of stool donations for FMT.
• Endoscopy control' subjects:
• \- Subjects with a medical indication for digestive endoscopy with biopsies:
• For upper endoscopy: moderate upper digestive symptoms such as epigastralgia or pyrosis
• For colonoscopy: moderate digestive symptoms suggestive of irritable bowel syndrome or screening for colorectal cancer.

You may not qualify if:

• For all patients and control subjects
• Subjects under guardianship, curatorship or safeguard of justice.
• Subjects who do not speak French.
• IBD patients:
• \- Colon preparation within 6 weeks before stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
• Endoscopy control' and "microbiota control" subjects:
• Subject suffering from a chronic disease
• Antibiotics taken in the 6 weeks prior to endoscopy
• Antibiotics or colonic preparation taken within 6 weeks prior to stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Sorbonne University: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection; Defecation; Biopsy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Harry SOKOL, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry SOKOL, MD, PhD01

CONTACT

+ 33 1 49 28 31 62; harry.sokol@aphp.fr

Philippe Seksik, MD, PhD

CONTACT

+ 33 1 49 28 31 62; philippe.seksik@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: September 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2040
• Study Completion (Estimated): November 1, 2040
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share