Evolution of Fatigue in Patients With Inflammatory Bowel Disease
NCT ID: NCT04189692
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
202 participants
OBSERVATIONAL
2020-01-07
2020-12-07
Brief Summary
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Detailed Description
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Recent publications have tried to assess the prevalence and factors related to fatigue in patients with IBD.
In 2017 one study evaluated the prevalence and predictive factors of fatigue in out-patients with inflammatory bowel disease. Fatigue was associated with depression, low quality of life and female sex. No association was found with micronutrients or levels of interleukins.
As there are no effective treatments for fatigue in IBD, another study, recently published a study evaluating the role of electroacupuncture in 54 patients with quiescent IBD and fatigue, observing that both electroacupuncture and sham acupuncture improved fatigue compared to the control group.
The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in the two previous studies.
Patients with inflammatory bowel disease and fatigue (FACIT-F score \< 40) included in these two previous studies who agree to participate will fill in questionnaires to assess fatigue, anxiety, depression and quality of life in inflammatory bowel disease. Moreover, the relationship of other biological factors with IBD-related fatigue will be determined.
Conditions
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Patients with Inflammatory Bowel Disease and fatigue
Patients with Inflammatory Bowel Disease and fatigue that participated in the two studies (1,2).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Written informed consent after receiving clear and objective information about the purpose and characteristics of the study.
* Ability to understand the questionnaires.
Exclusion Criteria
* Pregnancy or breastfeeding.
* Anemia (hemoglobin \<12g/dl in women and 14g/dl in men)
* Any concomitant illness that may justify the presence of fatigue.
18 Years
ALL
No
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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Diana Horta-Sangenis
gastroenterologist physician
Principal Investigators
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Diana Horta
Role: PRINCIPAL_INVESTIGATOR
Parc Tauli Hospital. Sabadell , Barcelona, Spain, 08208
Central Contacts
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References
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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.
Horta D, Lira A, Sanchez-Lloansi M, Villoria A, Teggiachi M, Garcia-Rojo D, Garcia-Molina S, Figuerola A, Esteve M, Calvet X. A Prospective Pilot Randomized Study: Electroacupuncture vs. Sham Procedure for the Treatment of Fatigue in Patients With Quiescent Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Feb 11;26(3):484-492. doi: 10.1093/ibd/izz091.
Other Identifiers
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HMT3
Identifier Type: -
Identifier Source: org_study_id