NKT Role in the Regulation of the Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Primary Sclerosing Cholangitis
• Interventions: Other: collection of gut biopsies collection of blood samples

• Registration Number: NCT02884557
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Primary Completion: 2019-08-27
• Study Completion: 2019-08-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSC + IBD group	collection of gut biopsies collection of blood samples	collection of gut biopsies collection of blood samples in patients with PSC and IBD
IBD alone group	collection of gut biopsies collection of blood samples	collection of gut biopsies collection of blood samples in patients with IBD alone

Primary Outcome Measures

Name	Time	Method
The increase in the expression of the NKT marker Valpha24 mRNA by PCR in the colon of patients with PSC alone, PSC + IBD compared to patients with IBD alone	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
The number of NKT infiltrating colonic biopsies, using immunohistochemical staining	Through study completion, an average of 1 year
The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry	At the time of the inclusion

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France