NKT Role in the Regulation of the Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

— NKT-CSP/MICI  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884557
• Other study ID #: 2011_06
• Secondary ID: 2012-A00493-40
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: August 28, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 28, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Primary Sclerosing Cholangitis

Intervention

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.

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of NKT infiltrating colonic biopsies, using immunohistochemical staining		Through study completion, an average of 1 year
Secondary	The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry		At the time of the inclusion