Fatigue in chronic liver disease: risk factors and treatment options

Not Applicable

• Conditions: Primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC); Digestive System; Cholangitis

• Registration Number: ISRCTN14379650
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36600365/ (added 06/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-05
• Last Update Posted: 8 January 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Clinical diagnosis of PBC (PSC)
2. Sufficient oral and written German language proficiency
3. Provision of written consent

Exclusion Criteria

1. Advanced cirrhosis (Child Pugh score =8)
2. Decompensated liver disease (autoimmune hepatitis or chronic viral hepatitis B or C)
3. Clinically significant untreated intercurrent medical condition associated with fatigue (i.e. hypothyroidism, anaemia, fibromyalgia, rheumatoid arthritis, systemic lupus erythematosus and manifest depression)
4. Antibiotic treatment during the past 6 weeks (exclusion only in microbiome study)
5. Ongoing participation in clinical trials on fatigue
6. Intercurrent active or latent infection
7. Florid psychosis
8. Substance abuse disorder
9. Acute suicidality

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of fatigue assessed using the Fatigue Visual Analogue Scale (Fatigue-VAS) score and the Primary Biliary Cirrhosis-40 (PBC-40) fatigue domain score at baseline, after 6 months, and after 12 months

Secondary Outcome Measures

Name	Time	Method
1. Total somatic symptom severity measured using the Patient Health Questionnaire-15 (PHQ-15) at baseline, 6 months, and 12 months<br>2. Symptom intensity measured using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months<br>3. Pruritus severity measured using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months<br>4. Symptom interference with daily activities using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months<br>5. Symptom-related disability measured using the Pain Disability Index (PDI) at baseline, 6 months, and 12 months<br>6. General mental and physical quality of life measured using the Short-Form Health Survey (SF-12) at baseline, 6 months, and 12 months<br>7. Disability-specific quality of life measured using the respective subdomain of the Primary Biliary Cirrhosis-40 (PBC-40) at baseline, 6 months, and 12 months