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临床试验/NCT04998084
NCT04998084招募中不适用

Understanding the Importance of the Microbiome and Metabolome in IBD Patients

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Clinical response as determined by a decrease in Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) decrease of ≥3 points among CD and UC patients respectively.

研究概览

简要总结

The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.

详细描述

The study is aim to detect common microbial profiles and metabolic pathways in patients belonging to the following groups:

  1. Therapy naïve newly diagnosed Crohn's disease (CD), ulcerative colitis (UC) and pouchitis patients. Studying this group of patients will enable the detection of microbial profiles associated with disease onset.
  2. Patients planned to commence biological therapy (with or without IBD). Studying this group of patients will enable the detection of microbial profiles associated with response to biological therapy.
  3. IBD patients in complete remission (treated or untreated with biologics). Following this group of patients will enable the detection of microbial profiles associated with disease exacerbation.

Methods:

Study design: A prospective cohort study. Setting: The investigators will prospectively collect clinical, behavioral and environmental data of patients participating in the study. Data will be collected according to a uniform standardized protocol specifically adapted to the needs of the study and shared between the collaborators.

Study population: Eligible patients, who sign an informed consent form and answer to all the study inclusion criteria. Patients will be informed of the study by their treating physician, recruited and followed throughout the follow-up period by study coordinators.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who belong to one of the following sub-groups:
  • Newly diagnosed (<1 years), therapy naïve IBD and pouchitis patients
  • IBD patients in complete remission (treated or untreated with biologics)
  • Patients (with and without IBD) scheduled to commence a biological therapy

排除标准

  • Age≤18 years
  • Inability to sign an informed consent
  • Abdominal surgery during the previous 3 months
  • Systemic antibiotic therapy in the previous 4 weeks
  • Severe systemic disease such as kidney, liver, neurologic, cardio-vascular disease
  • Primary sclerosing cholangitis
  • Pregnancy at recruitment
  • Cancer within the previous 5 years excluding local NMSC

结局指标

主要结局

Clinical response as determined by a decrease in Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) decrease of ≥3 points among CD and UC patients respectively.

时间窗: 2019-2024

Biologic response as determined by a decrease in C-Reactive Protein (CRP), fecal calprotectin >10% from baseline.

时间窗: 2019-2024

Improvement in patient quality of sleep score

时间窗: 2019-2024

as determined by a decrease of \>10% from baseline.

Improvement in patient quality of life score

时间窗: 2019-2024

as determined by a decrease of \>10% from baseline.

Improvement in stress score

时间窗: 2019-2024

Clinical response as determined by the Harvie Bradshaw Index (HBI)>3 points among crohn's patients

时间窗: 2019-2024

Clinical response as determined by the Simple Clinical Colitis Activity Index (SCCAI)>3 points among UC patients

时间窗: 2019-2024

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eli Sprecher, MD

Director of Clinical Research and Development Department

Tel-Aviv Sourasky Medical Center

研究点 (1)

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