NKT Role in the Regulation of the Inflammatory Bowel Disease

NCT02884557 | Completed

• 2 other identifiers: 2011_062012-A00493-40
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

PSC + IBD group

OTHER

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

Other: collection of gut biopsies collection of blood samples

IBD alone group

OTHER

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

Other: collection of gut biopsies collection of blood samples

Interventions

collection of gut biopsies collection of blood samples OTHER

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

IBD alone group; PSC + IBD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Pierre Desreumeaux, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 31, 2016
• Study Start: May 1, 2013
• Primary Completion: August 27, 2019
• Study Completion: August 28, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)