Trials / Completed
CompletedNCT04191707
Metabolomic Markers of Fatigue in Inflammatory Bowel Disease
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 18 (actual)
- Sponsor
- Corporacion Parc Tauli · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2019-12-10
- Last updated
- 2019-12-10
Source: ClinicalTrials.gov record NCT04191707. Inclusion in this directory is not an endorsement.