Fatigue in chronic liver disease: risk factors and treatment options

Fatigue in primary biliary cholangitis: factors associated with severity and persistence as future therapeutic targets

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14379650

Enrollment

480

Registered

2021-11-05

Start date

2022-03-21

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) Digestive System Cholangitis

Interventions

A prospective cohort study will be conducted in order to compare fatigue experience and related factors in patients with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). Usi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Total somatic symptom severity measured using the Patient Health Questionnaire-15 (PHQ-15) at baseline, 6 months, and 12 months 2. Symptom intensity measured using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months 3. Pruritus severity measured using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months 4. Symptom interference with daily activities using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months 5. Symptom-related disability measured using the Pain Disability Index (PDI) at baseline, 6 months, and 12 months 6. General mental and physical quality of life measured using the Short-Form Health Survey (SF-12) at baseline, 6 months, and 12 months 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	—

Measure

Time frame

1. Total somatic symptom severity measured using the Patient Health Questionnaire-15 (PHQ-15) at baseline, 6 months, and 12 months 2. Symptom intensity measured using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months 3. Pruritus severity measured using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months 4. Symptom interference with daily activities using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months 5. Symptom-related disability measured using the Pain Disability Index (PDI) at baseline, 6 months, and 12 months 6. General mental and physical quality of life measured using the Short-Form Health Survey (SF-12) at baseline, 6 months, and 12 months 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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026