Immunological Profiles in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients
研究概览
简要总结
Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.
详细描述
Rationale: Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.
Objective: Determine if assessment of mucosal and serological immunological characteristics in combination with clinical indicators of disease behaviour and response to therapy can identify immune-based phenotypes with implications for prognosis and therapeutic interventions.
Study design: The study will be a longitudinal, prospective cohort study. Study population: The study population will include newly diagnosed adults fulling the diagnostic criteria for IBD. These patients will be further studied as a follow up cohort.
Intervention: Immunological analysis of extra mucosal biopsies and venous bloodsamples taken during regular ileocolonoscopy and labcontrols at initial diagnosis and during follow up.
Main study parameters/endpoints: The description of the different mucosal and serological immunological profiles at baseline and follow up in newly diagnosed IBD patients and the correlation between these different immunological profiles and clinical indicators of disease activity, disease course and response to the received therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A patient who meets the following criteria will be included in this study:
- •Patients with clinical symptoms of chronic diarrhoea, rectal blood loss, abdominal pain or weight loss who underwent ileocolonoscopy. Macroscopic findings during ileocolonoscopy must suggest IBD, such as erythema, mucosal friability, oedema an bleeding, erosions, superficial or deep ulcerations and luminal narrowing.
- •Ultimately, the diagnosis of IBD must be based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria.
- •Patients must be able and willing to provide written informed consent.
- •Patients above the age of 18, both men and women. AND/OR
- •Known IBD patients under treatment during follow up.
排除标准
- •A patient who meets any of the following criteria will be excluded from participation in this study:
- •Possible new IBD patients who use immunosuppressive medication 4 weeks prior to inclusion (e.g. corticosteroids and anti-TNF therapy) either for IBD, other autoimmune diseases or after organ transplantation.
- •Patients diagnosed with an immune suppressive disease.
- •Patients who underwent splenectomy in the past.
- •Patients diagnosed with any other autoimmune diseases (e.g. Diabetes Mellitus type I, rheumatoid arthritis, celiac disease, psoriasis, systemic lupus erythematosus).
- •Patients diagnosed with cancer including hematologic malignancies (e.g. (non-)Hodgkin lymphoma , leukemia), solid tumors and carcinoma in situ, within 5 years before screening with the following caveats:
- •Local basal or squamous cell carcinoma of the skin that has been excised and is considered cured is not exclusionary.
- •Chronic myelogenous leukemia, hairy cell leukemia, melanoma, renal cell carcinoma, or Kaposi sarcoma are exclusionary irrespective of the duration of time before screening.
- •Cervical smear indicating the presence of adenocarcinoma I situ (AIS), high-grade squamous intraepithelial lesions (HSIL), or cervical intraepithelial neoplasia (CIN) of grade>1, is exclusionary, irrespective of the duration of time before screening.
- •Follow up IBD-patients who underwent a total colectomy in the past.
结局指标
主要结局
The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients
时间窗: 10-2017 till 6-2020
The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients
次要结局
- The correlation between these different immunologic profiles and clinical indicators of disease activity, disease course and response to the received therapy.(10-2017 till 6-2020)
研究者
Roosenboom
Principal Investigator
Rijnstate Hospital