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临床试验/NCT04191707
NCT04191707已完成不适用

Metabolomic Markers of Fatigue in Inflammatory Bowel Disease

Corporacion Parc Tauli0 个研究点目标入组 18 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
主要终点
changes in metabolomic profile

研究概览

简要总结

Fatigue is a common symptom and a leading concern in patients with inflammatory bowel disease (IBD) and often persists despite clinical and endoscopic remission.

This study evaluates the metabolomic profile of fatigued patients with IBD.

详细描述

To date, there is only one non-published study using metabolomics in quiescent IBD patients with and without fatigue.

The investogators designed this study to examine if there are metabolomics factors associated to fatigue in IBD patients.

This study was performed with plasma samples from IBD patients recruited in a previous study after informed consent. (1) IBD outpatients attending the Hospital de Sabadell Gastroenterology Day-care unit were consecutively included for analytical monitoring of immunosuppressant treatment or infliximab infusion.

The investigators recorded demographic data, IBD classification according to the Montreal classification, and history of drug administration. In addition, clinical activity of the disease was measured using the Harvey-Bradshaw score for Crohn's disease (CD) and the modified Mayo score for ulcerative colitis (UC). The "Functional Assessment of chronic Illness Therapy-Fatigue" (FACIT-F) was used to assess fatigue.

研究设计

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

入排标准

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

入选标准

  • Inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) .

排除标准

  • Age below 18 years.
  • Refusal to give written informed consent prior to participation
  • Active infection at the time of inclusion.
  • Concomitant diseases not related to IBD (e.g., cancer, heart disease, pulmonary disease) that might contribute to the presence or the severity of fatigue.
  • Active flare of IBD in the last 3 months.

结局指标

主要结局

changes in metabolomic profile

时间窗: 1 year

The metabolic profile consisted in 75 metabolites that were measured

次要结局

未报告次要终点

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana Horta-Sangenis

principal investigator

Corporacion Parc Tauli

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