An observational study in Inflammatory Bowel Disease, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Observational
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.
1,487 studies on the registry are indexed under Inflammatory Bowel Diseases; 434 are open to participants now.
This study's enrollment of 45 is below the median of 146 across 659 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
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healthy controls and patients with active inflammatory bowel disease (ulcerative colitis and Crohn´s disease).
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Patients with active IBD, and endoscopic and histological diagnosis of CD or UC that attend a colonoscopy with sedation performed by medical criteria.
Patients without an IBD diagnosis, or other types of inflammatory, allergic, malignant or autoimmune diseases, prior to their inclusion in this project. All patients will attend a colonoscopy with sedation at medical judgment with biopsy indication for histopathological study as in cases of diarrhea but also due to changes in the bowel transit, rectal bleeding or screening for gastrointestinal diseases. Patients will be paired in age and gender with the IBD groups. All patients will have no signs of macroscopic or microscopic inflammation hence excluding the presence of microscopic colitis.
Exclusion Criteria:
Biological: Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab
Biological: Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab
Biological: Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab
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.
Effect of biological drugs on the secretion of gut-chemoattractants by the intestinal mucosa
To assess, ex-vivo, the capacity of the IBD mucosa to recruit subsets of circulating leukocytes following mucosal conditioning with biological drugs.
Time frame: 18 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2016 to primary completion in Dec 2017, 20 months.
Of 251 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 148. This study's 20 months is below that.
Counting every sponsor, half of 288 studies reached it within 38 months; a quarter within 20 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa