Evolution of Fatigue in Patients With Inflammatory Bowel Disease

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.

Study Overview

• Status: Unknown
• Conditions: Fatigue; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

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.

• Study Type: Observational
• Enrollment (Anticipated): 202

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years	Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F scale). This questionnaire, previously validated in Spanish and for IBD patients, comprises 40 items divided into five subscales: Physical wellbeing (PWB), Social/family wellbeing (SWB), Emotional wellbeing (EWB), Functional Wellbeing (FWB), and Fatigue subscale. The first four subscales (27 items) evaluate general features of chronic illness, and the 13 items of the Fatigue subscale specifically focus on fatigue. Each item has five possible answers, from 0 (very fatigued) to 4 (not at all fatigued). The score of each subscale is the sum of the coded values of its items.	three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the biological factors associated with the persistence of fatigue	Assessed by a blood test including micronutrients (vitamin B12, ferritin and vitamin D).	three years
Assess the psychological factors associated with the persistence of fatigue	Assessed by the Beck Depression Inventory (BDI) questionnaire. The Spanish validated 21-item version of the BDI will be used to analyze depression. This self-administered questionnaire evaluates the clinical features of melancholy and intrusive thoughts present in depression. Each item has a different number of options (from 4 to 8), which then have to be converted into four possible values (0, 1, 2, or 3). Higher BDI scores indicate a higher grade of depression.	three years
Assess the psychological factors associated with the persistence of fatigue	Assessed by Quality of life in inflammatory bowel disease questionnaire (IBDQ-9). he IBDQ-9 consists of nine items assessing different aspects of life in IBD patients. Each item has seven different possible answers, scoring from 1 (poorest) to 7 (best). The straight summation of all nine items provides a direct score, which is then transformed into a final score. Higher scores correspond to a better quality of life.	three years

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Diana Horta, Parc Tauli Hospital. Sabadell , Barcelona, Spain, 08208

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 7, 2020
• Primary Completion (Anticipated): December 7, 2020
• Study Completion (Anticipated): December 7, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Crohn Disease; Inflammatory Bowel Diseases; Fatigue
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Fatigue; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: HMT3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No