Metabolomic Markers of Fatigue in Inflammatory Bowel Disease
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
- 否
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
Diana Horta-Sangenis
principal investigator
Corporacion Parc Tauli