NKT Role in the Regulation of the Inflammatory Bowel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-08-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases Primary Sclerosing Cholangitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PSC + IBD group

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

Group Type OTHER

collection of gut biopsies collection of blood samples

Intervention Type OTHER

Four to eight colon biopsies will be sampled during endoscopy. Thirty milliliters of blood will be sampled.

IBD alone group

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

Group Type OTHER

collection of gut biopsies collection of blood samples

Intervention Type OTHER

Four to eight colon biopsies will be sampled during endoscopy. Thirty milliliters of blood will be sampled.

Interventions

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collection of gut biopsies collection of blood samples

Four to eight colon biopsies will be sampled during endoscopy. Thirty milliliters of blood will be sampled.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No