Metabolomic Markers of Fatigue in Inflammatory Bowel Disease
1 other identifier
observational
18
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2013
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedDecember 10, 2019
December 1, 2019
6.1 years
December 3, 2019
December 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
changes in metabolomic profile
The metabolic profile consisted in 75 metabolites that were measured
1 year
Study Arms (1)
Outpatients with Inflammatory Bowel Disease
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
Eligibility Criteria
This study was performed with plasma samples from IBD patients recruited in a previous study after informed consent.
You may qualify if:
- \- Inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) .
You may not qualify if:
- Age below 18 years.
- Refusal to give written informed consent prior to participation
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Villoria A, Garcia V, Dosal A, Moreno L, Montserrat A, Figuerola A, Horta D, Calvet X, Ramirez-Lazaro MJ. Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors. PLoS One. 2017 Jul 27;12(7):e0181435. doi: 10.1371/journal.pone.0181435. eCollection 2017.
PMID: 28749985BACKGROUND
Biospecimen
5 ml of peripheral blood by venepuncture into EDTA-K3 tubes (BD Biosciences, Spain). Plasma was separated by centrifugation of the samples at 2400 g for 10 min at 4°C and stored at - 80°C until analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana Horta
Parc Tauli Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 10, 2019
Study Start
November 1, 2013
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
December 10, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share