Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract
研究概览
简要总结
In this study, the investigators will explore our protein-based platform assessing commensals potentially contributing to features of CD, while assessing the global composition and abundance of AMPs expressed in the GI tract under specific CD-relevant clinical contexts. This would enable us to (a) identify new commensals contributing to features of CD spectrum and various sub-types; (b) uncover the mechanistic basis of dysbiosis in CD (c) utilize the pipeline to develop new theranostic for disease exacerbation, complication and treatment responses; and (d) potentially enable future exploitation of novel AMP combinations, and their respective antimicrobial capacity to counteract dysbiosis in CD.
Uncovering the proteomic manifestations of perturbed host-microbiome communications in CD will eventually enable the development and validation of clinical non-invasive surrogate markers, mechanistically determine causative drivers of CD, and potentially facilitate the development of novel therapeutic interventions.
详细描述
Participants will be recruited from a community outpatient clinics and from a leading outpatient gastroenterology clinic: Emek Medical Center, after ICF signing , they will fill out a medical, demographic, and lifestyle habits questionnaires, as well as a food frequency questionnaire (FFQ). Participants will receive a home stool kit and will be instructed on how to use it. They will also receive a kit and an explanation regarding preparation materials for the colonoscopy. Subjects will be asked to collect stool samples at home - prior to colonoscopy and if possible - after colonoscopy bowel prep.
The second visit of the study will occur on the day of colonoscopy. Each patient will be clinically assessed by a gastroenterologist using the Crohn's Disease Activity Index (CDAI)30 and Harvey-Bradshaw Index (HBI); and collection of luminal, brush cytology, and mucosal samples from 4 different lower intestine regions
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
- •CD study group:
- •Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.
- •Naïve to any medical or nutritional intervention.
- •Inclusion criteria - healthy controls:
- •Age- and gender-matched patients to the CD group, admitted for non-specific GI complaints (such as changes in bowel movements, bloating, abdominal pain) or routine screening for colorectal cancer as part of primary prevention per clinical guidelines.
排除标准
- •both groups:
- •Established diagnosis of inflammatory bowel disease (IBD) with prior treatment.
- •Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
- •Type 1 or type 2 diabetes mellitus.
- •Past or present history of malignancy.
- •BMI > 30 (kg/m2)
- •Use of systemic antibiotics or probiotics 2 months prior to enrolment.
- •Use of steroids 2 months prior to enrolment (not including a short course of topical steroidal therapy).
- •Any previous major gastric or intestinal surgery.
- •Suspected or proven extensive involvement of non-ileal small intestine or colon, or significant perianal disease.
- •Significantly stricturing or penetrating (fistulizing) disease at presentation.
- •Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalers/creams/ointments should not be excluded from the study.
- •Primary immunodeficiency.
- •Pregnancy or breastfeeding in the last 6 months.
- •Serious medical conditions that may alter the gut microbiome composition, based on investigators judgement (for example primary immunodeficiency, autoimmune disorder, or rheumatologic disease).
研究组 & 干预措施
healthy controls
healthy participants admitted for non-specific GI complaints (such as changes in bowel movements, bloating, abdominal pain) or routine screening for colorectal cancer as part of primary
干预措施: colonoscopy procedure (Other)
crohn disease patients
Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.
干预措施: colonoscopy procedure (Other)
结局指标
主要结局
Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract
时间窗: 1 week
Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples, biopsies and brushes collected during endoscopy
次要结局
未报告次要终点