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OpenTrials
Completed

NCT Number: NCT02884557

NKT Role in the Regulation of the Inflammatory Bowel Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU, Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collection of gut biopsies collection of blood samples

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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)

Acronym: NKT-CSP/MICI

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2016
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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