Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT04189692
Status:
UNKNOWN
Last Update Posted:
2019-12-06
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution of Fatigue in Patients With Inflammatory Bowel Disease
Sponsor:
Corporacion Parc Tauli
Organization:
Study Overview
Official Title:
Evolution of Fatigue in Patients With Inflammatory Bowel Disease
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 two previous studies.
Detailed Description:
Fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: