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

Evaluation of the Expression of Natural Killer T Cells (NKT) Marker in the Gut of Patients With Primary Sclerosing Cholangitis (PSC) Complicated by an Inflammatory Bowel Disease (IBD)

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Primary Sclerosing Cholangitis
• Intervention / Treatment: Other: collection of gut biopsies collection of blood samples

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHRU, Hôpital Claude HURIEZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PSC + IBD group; collection of gut biopsies collection of blood samples in patients with PSC and IBD	Other: 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.
Other: IBD alone group; collection of gut biopsies collection of blood samples in patients with IBD alone	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): August 27, 2019
• Study Completion (Actual): August 28, 2019

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Biliary Tract Diseases; Bile Duct Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Cholangitis; Cholangitis, Sclerosing
• Other Study ID Numbers: 2011_06; 2012-A00493-40 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No