NKT Role in the Regulation of the Inflammatory Bowel Disease (NKT-CSP/MICI)

University Hospital, Lille

Status: Completed

Conditions: Primary Sclerosing Cholangitis; Inflammatory Bowel Diseases

Treatments: Other: collection of gut biopsies collection of blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02884557

2011_06

2012-A00493-40 (Other Identifier)

Details and patient eligibility

About

Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation.

Based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with PSC alone, IBD alone or PSC + IBD
• Obtention of oral and written consent
• Patients affiliated with the social security system

Exclusion criteria

• Minor patient
• Suspicion of malignant lesion of the colon
• Inability for information
• person unable to consent, and not benefiting from a legal protection regimen
• Person deprived of liberty

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

PSC + IBD group

Other group

Description:

collection of gut biopsies collection of blood samples in patients with PSC and IBD

Treatment:

Other: collection of gut biopsies collection of blood samples

IBD alone group

Other group

Description:

collection of gut biopsies collection of blood samples in patients with IBD alone

Treatment:

Other: collection of gut biopsies collection of blood samples