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NKT Role in the Regulation of the Inflammatory Bowel Disease

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02884557
Acronym
NKT-CSP/MICI
Enrollment
64
Registered
2016-08-31
Start date
2013-05-31
Completion date
2019-08-28
Last updated
2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Primary Sclerosing Cholangitis

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.

Interventions

OTHERcollection of gut biopsies collection of blood samples

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 aloneThrough study completion, an average of 1 year

Secondary

MeasureTime frame
The number of NKT infiltrating colonic biopsies, using immunohistochemical stainingThrough study completion, an average of 1 year
The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometryAt the time of the inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026