Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Effect of biological drugs on the secretion of gut-chemoattractants by the intestinal mucosa
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Effect of biological drugs on the secretion of gut-chemoattractants by the intestinal mucosa
时间窗: 18 months
To assess, ex-vivo, the capacity of the IBD mucosa to recruit subsets of circulating leukocytes following mucosal conditioning with biological drugs.
次要结局
未报告次要终点
研究者
Javier P. Gisbert
PhD, MD
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa