Evolution of Fatigue in Patients With Inflammatory Bowel Disease

Corporacion Parc Tauli

Status: Unknown

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Fatigue; Crohn Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04189692

HMT3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

202 participants in 1 patient group

Patients with Inflammatory Bowel Disease and fatigue

Description:

Patients with Inflammatory Bowel Disease and fatigue that participated in the two studies (1,2).