NKT Role in the Regulation of the Inflammatory Bowel Disease (NKT-CSP/MICI)
Primary Purpose
Inflammatory Bowel Diseases, Primary Sclerosing Cholangitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
collection of gut biopsies collection of blood samples
Sponsored by
About this trial
This is an interventional basic science trial for Inflammatory Bowel Diseases
Eligibility 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
Sites / Locations
- CHRU, Hôpital Claude Huriez
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PSC + IBD group
IBD alone group
Arm Description
collection of gut biopsies collection of blood samples in patients with PSC and IBD
collection of gut biopsies collection of blood samples in patients with IBD alone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The number of NKT infiltrating colonic biopsies, using immunohistochemical staining
The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry
Full Information
NCT ID
NCT02884557
First Posted
August 23, 2016
Last Updated
August 26, 2020
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT02884557
Brief Title
NKT Role in the Regulation of the Inflammatory Bowel Disease
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Primary Sclerosing Cholangitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSC + IBD group
Arm Type
Other
Arm Description
collection of gut biopsies collection of blood samples in patients with PSC and IBD
Arm Title
IBD alone group
Arm Type
Other
Arm Description
collection of gut biopsies collection of blood samples in patients with IBD alone
Intervention Type
Other
Intervention Name(s)
collection of gut biopsies collection of blood samples
Intervention Description
Four to eight colon biopsies will be sampled during endoscopy. Thirty milliliters of blood will be sampled.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The number of NKT infiltrating colonic biopsies, using immunohistochemical staining
Time Frame
Through study completion, an average of 1 year
Title
The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry
Time Frame
At the time of the inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Desreumeaux, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NKT Role in the Regulation of the Inflammatory Bowel Disease
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