Clinical trial NCT04189692: Evolution of Fatigue in Patients With Inflammatory Bowel Disease
Official title: Evolution of Fatigue in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fatigue
Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Keywords: Fatigue;
Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with IBD and fatigue included in the two previous studies (1,2) (n = 202) who agree to participate.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory bowel disease and fatigue (defined as a FACIT-F score \<40 points) previously documented in our two previous studies.
* Written informed consent after receiving clear and objective information about the purpose and characteristics of the study.
* Ability to understand the questionnaires.

Exclusion Criteria:

* Associated tumor disease.
* Pregnancy or breastfeeding.
* Anemia (hemoglobin \<12g/dl in women and 14g/dl in men)
* Any concomitant illness that may justify the presence of fatigue.

Primary outcomes:
measure: Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years
timeFrame: three years
Secondary outcomes:
measure: Assess the biological factors associated with the persistence of fatigue
timeFrame: three years
measure: Assess the psychological factors associated with the persistence of fatigue
timeFrame: three years
measure: Assess the psychological factors associated with the persistence of fatigue
timeFrame: three years
Other outcomes:
Locations:
Study officials:
affiliation: Parc Tauli Hospital. Sabadell , Barcelona, Spain, 08208
name: Diana Horta
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.