ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 29 for:    Recruiting, Not yet recruiting Studies | Primary Sclerosing Cholangitis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02884557
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Primary Sclerosing Cholangitis Other: collection of gut biopsies collection of blood samples Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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)
Study Start Date : May 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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 [ Time Frame: Through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. The number of NKT infiltrating colonic biopsies, using immunohistochemical staining [ Time Frame: Through study completion, an average of 1 year ]
  2. The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry [ Time Frame: At the time of the inclusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884557


Contacts
Contact: Pierre Desreumeaux, MD,PhD pdesreumaux@hotmail.com

Locations
France
CHRU, Hôpital Claude Huriez Recruiting
Lille, France
Principal Investigator: Pierre Desreumaux, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Pierre Desreumeaux, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02884557     History of Changes
Other Study ID Numbers: 2011_06
2012-A00493-40 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Cholangitis
Cholangitis, Sclerosing
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Bile Duct Diseases
Biliary Tract Diseases