Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4,500
- 主要终点
- Relation between biological parameters (fecal and ileal microbiome) and outcomes of IBD
研究概览
简要总结
Inflammatory Bowel Diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic, disabling conditions affecting young adults, marked by flare-ups and remissions. Traditionally, IBD was treated with immunosuppressants like thiopurines, but new biological treatments, such as anti-TNFa antibodies (e.g., infliximab, adalimumab), have transformed management. Biologics often combine with thiopurines but come with risks, like increased chances of skin cancers and lymphomas, especially for prolonged use in young patients. Recently, newer biologics (e.g., ustekinumab, vedolizumab) and small molecules like JAK inhibitors have expanded treatment options.
The exact cause of IBD remains unknown, though an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals is suspected. Dysbiosis, or imbalance in gut microbiota, has been linked to IBD, with reductions in 'beneficial' bacteria and increases in harmful ones. Certain bacteria, like Faecalibacterium prausnitzii, may serve as markers for disease activity or progression.
Due to the heterogeneity of UC and CD, it is crucial to identify early predictive factors for complications and treatment response. This study aims to identify biological markers of disease course and complications in IBD and to deepen understanding of its pathophysiological mechanisms.
详细描述
Inflammatory Bowel Diseases (IBD) are chronic, disabling conditions that affect young adults with a predilection for flare-ups interspersed with periods of remission. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD.
IBD is a chronic disease, the course of which is often marked by complications. Until recently, the medical treatment of IBD was based on the use of immunosuppressants, particularly thiopurines. The management of IBD has been modified in recent years by the appearance of new so-called 'biological' treatments. Anti-TNFa antibodies (such as infliximab or adalimumab) represent, highly effective weapon in the arsenal available for treating IBD. Biological treatments appear to have a synergistic effect with thiopurines and their administration is therefore often concomitant. These immunosuppressive and biological treatments are not harmless, especially as they are taken for prolonged periods by young patients. In particular, the use of thiopurines is associated with a marked increase in the risk of non-melanoma skin cancers and lymphomas. The long-term risks of biological treatments are still poorly understood. For the treatment of IBD, there are now much more biologics available, including Ustekinumab, vedolizumab and also small molecules, such as JAK inhibitors.
Despite recent advances, the cause of IBD remains unknown. The currently dominant hypothesis is that of an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals.
In humans, an imbalance in the composition of the intestinal microbiota (dysbiosis) has been demonstrated in patients with CD and UC, with a reduction in 'beneficial' bacteria and an increase in potentially 'harmful' bacteria. Finally, certain bacteria in the intestinal microbiota could be used as a marker of disease activity or as a predictive factor for progression, as we have shown with the Faecalibacterium prausnitzii bacterium and postoperative recurrence of Crohn's disease.
Given the phenotypic heterogeneity of UC and CD in terms of progression and complications, it is essential to identify predictive factors that will enable patients at risk to be identified as early as possible so that treatment can be adapted at an early stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •For all patients and control subjects
- •Person able to give free and informed consent.
- •Age ≥ 18 years.
- •Beneficiary of a social protection scheme or entitled person (excluding AME).
- •Consultation in the Gastroenterology and Nutrition Department of Saint-Antoine Hospital
- •Patients with IBD :
- •- Patients with Crohn's disease or haemorrhagic rectocolitis with a diagnosis established or confirmed in the Gastroenterology and Nutrition Department at Saint-Antoine Hospital.
- •Microbiota control' subjects:
- •- Healthy subjects seen in consultation as a preventive measure or as part of stool donations for FMT.
- •Endoscopy control' subjects:
- •- Subjects with a medical indication for digestive endoscopy with biopsies:
- •For upper endoscopy: moderate upper digestive symptoms such as epigastralgia or pyrosis
- •For colonoscopy: moderate digestive symptoms suggestive of irritable bowel syndrome or screening for colorectal cancer.
排除标准
- •For all patients and control subjects
- •Subjects under guardianship, curatorship or safeguard of justice.
- •Subjects who do not speak French.
- •IBD patients:
- •- Colon preparation within 6 weeks before stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
- •Endoscopy control' and "microbiota control" subjects:
- •Subject suffering from a chronic disease
- •Antibiotics taken in the 6 weeks prior to endoscopy
- •Antibiotics or colonic preparation taken within 6 weeks prior to stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
研究组 & 干预措施
Patients with Inflammatory Bowel Diseases
干预措施: Blood, fecal, saliva (Other)
Patients with Inflammatory Bowel Diseases
干预措施: intestinal content samples and biopsies (Other)
Microbiota control' subjects
干预措施: Blood, fecal, saliva (Other)
Endoscopy control' subjects
干预措施: Blood, fecal, saliva (Other)
Endoscopy control' subjects
干预措施: intestinal content samples and biopsies (Other)
结局指标
主要结局
Relation between biological parameters (fecal and ileal microbiome) and outcomes of IBD
时间窗: up to 12 months after the inclusion
identify relations between fecal and ileal microbiome and disease evolution
次要结局
未报告次要终点