Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells
1 other identifier
observational
45
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 2, 2017
CompletedFirst Posted
Study publicly available on registry
February 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2018
CompletedFebruary 25, 2019
February 1, 2019
1.8 years
February 2, 2017
February 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
18 months
Study Arms (3)
Non-inflamed
Inflamed ulcerative colitis
inflamed Crohn´s disease
Interventions
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.
Eligibility Criteria
healthy controls and patients with active inflammatory bowel disease (ulcerative colitis and Crohn´s disease).
You may qualify if:
- Patients with active IBD, and endoscopic and histological diagnosis of CD or UC that attend a colonoscopy with sedation performed by medical criteria.
You may not qualify if:
- Age less than 18 years
- Chronic disease or any other advanced clinically significant pathology, uncontrolled by investigator judgment.
- Should be with medication, this will be unchanged in the 3 months prior to colonoscopy.
- Alcohol or drugs.
- Pregnancy or lactation
- Do not sign the informed consent form (see "Ethical Issues") In any case NO colonoscopies exclusively targeted for sampling for this project will be made
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Cell culture supernatants
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD
Study Record Dates
First Submitted
February 2, 2017
First Posted
February 6, 2017
Study Start
April 1, 2016
Primary Completion
December 31, 2017
Study Completion
May 30, 2018
Last Updated
February 25, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share