The Role of CD4+ T Cell Subsets in the Mechanism of Action of Vedolizumab in Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT02721719|
Recruitment Status : Recruiting
First Posted : March 29, 2016
Last Update Posted : June 8, 2018
The cause of Inflammatory Bowl Disease (IBD) is not known, but studies from patients with IBD have found that these patients make unusually strong immune responses to their own intestinal tissues and to bacteria that normally live in the healthy gut. These overactive immune responses might result from an imbalance of T-lymphocytes, which are a type of white blood cell that recognize and respond to threats like infection or damaged tissues. In healthy tissues, a type of T-lymphocytes called T-regulatory cells control excess inflammation by preventing other T cells, called T-effector cells from responding. We believe that T-regulatory cells are somehow less active in IBD, resulting in damage to intestinal tissues by the T-effector cells.
T-lymphocytes, including both T-regulatory and T-effector cells, are guided to different parts of the body by 'alpha4beta7-integrin' molecules. Vedolizumab or Entyvio works by blocking this homing molecule so that T cells do not reach the intestine, but stay in the blood where they cannot aggravate your IBD. This study will help in understanding how Vedolizumab helps to heal or decrease the symptoms of your Ulcerative Colitis.
The effect of Vedolizumab on different types of T cells in the human intestine has not yet been studied. However, the investigators think that Vedolizumab will shift the balance of T cells in the intestine towards more healing T-regulatory cells and less damaging T-effector cells. The purpose of this study is to measure the different types of T cells in participants' blood and intestinal tissue before and during Vedolizumab treatment.
|Condition or disease|
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|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||The Role of CD4+ T Cell Subsets in the Mechanism of Action of Vedolizumab in Ulcerative Colitis|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||November 2019|
[Not receiving Vedolizumab] Healthy adults who have not donated blood within the past two months and who have no history of blood-borne diseases.
Adults with no Inflammatory Bowl Disease
[Not receiving Vedolizumab] Adult patients undergoing endoscopy for indications other than Inflammatory Bowel Disease or other inflammatory conditions of the bowel (such as colon cancer screening or polypectomy)
Donors with Ulcerative Colitis
[Set to receive Vedolizumab] Adults with an established diagnosis of UC (≥ 6 months preceding involvement in study) who are both scheduled for an endoscopy and are about to receive Vedolizumab treatment (standard of care).
- Differences in CD4+ T cell subsets in the blood and colonic tissue of IBD patients before and after Vedolizumab treatment; relative CD4+ T cell numbers will be determined by immunofluorescent detection of subset specific markers. [ Time Frame: Two years ]
- Differences in the stability of T regulatory cells with and without alpha4beta7 integrin binding as measured by maintenance of the Treg-specific-demethylation region in the FoxP3 promoter. [ Time Frame: Two years ]
- Differences in the suppressive capacity of T regulatory cells with and without alpha4beta7 integrin binding as measured by ability to suppress the proliferation of CD4+CD25- T effector cells. [ Time Frame: Two years ]
Biospecimen Retention: Samples Without DNA
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): NCT02721719
|Contact: Amy Wong, BSc||778 588 6700 ext email@example.com|
|Contact: Maria Ancheta-Schmit, RN, BSN||604 688 6332 ext firstname.lastname@example.org|
|Canada, British Columbia|
|Child and Family Research Institute||Recruiting|
|Vancouver, British Columbia, Canada, V5Z4H4|
|Contact: Sabine Ivison, PhD 604 875 2000 ext 6425 email@example.com|
|Principal Investigator: Megan Levings, PhD|
|Principal Investigator:||Brian Bressler, MD, FCRP(C)||University of British Columbia|