Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells

Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study ID
NCT03043677
Status
Completed

Conditions

  • Inflammatory Bowel Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab — BIOLOGICAL
    Ex-vivo conditioning of lamina propria and peripheral blood mononuclear cells. Here, we will address whether the current available biological therapies for IBD patients (infliximab, golimumab, adalimumab, vedolizumab and ustekinumab) elicit a differential effect on the mucosal capacity to recruit circulating leukocytes on an ex-vivo approach using transwell culture systems.

Study Details

To characterize circulating DC subsets from healthy controls and IBD patients and to assess, following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators on both the GI production of soluble immune mediators and the mucosal capacity to alter the recruitment capacity of circulating DC subsets. It is expected that such approach will provide further information on the action mechanisms of such therapies on IBD patients, allowing a better understanding of the pathophysiology of this disease and the identification of tissue-specific therapeutic targets, thus avoiding collateral problems associated with systemic immunomodulation.

Key Dates

Start date
Apr 1, 2016
Status verified
Feb 2019
Primary completion
Dec 31, 2017
Completion
May 30, 2018

Study Design

Enrollment
45 participants (actual)

Arms

  • Arm: Non-inflamed
  • Arm: Inflamed ulcerative colitis
  • Arm: inflamed Crohn´s disease

Primary Outcome Measure

Effect of biological drugs on the secretion of gut-chemoattractants by the intestinal mucosa [ Time Frame: 18 months ]

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