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Structured nutritional intervention for chronic fatigue in patients with primary biliary cholangitis: a cross-sectional and single-blinded randomized controlled clinical trial

Structured nutritional intervention for chronic fatigue in patients with primary biliary cholangitis: a cross-sectional and single-blinded randomized controlled clinical trial - FECH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036213
Enrollment
60
Registered
2026-02-03
Start date
2026-02-09
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

K74.3

Interventions

Group 1: Control arm Patients undergo laboratory and nutrition-related assessments, including body composition analysis and questionnaires on fatigue and quality of life, at baseline, 6 months, and 12

Sponsors

Universitätsklinikum Essen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Proven primary biliary cholangitis

Exclusion criteria

Exclusion criteria: Another autoimmune disease of the liver, which is not primary biliary cholangitis. Defibrillator Structural cardiac diseases Clinically significant anemia (Hb 15 points Lack of consent from the patient Severe and immediately life-threatening malnutrition in which harm cannot be averted without intervention

Design outcomes

Primary

MeasureTime frame
Following the structured nutritional intervention, fatigue levels differed between the intervention and control groups, as assessed by the PBC-40 and mFIS scores at 6 and 12 months.

Secondary

MeasureTime frame
In the cross-sectional design, patients with fatigue show a higher rate of objective criteria of malnutrition compared to patients without fatigue.

Countries

Germany

Contacts

Public ContactClaudia Veltkamp

Klinik für Gastroenterologie, Hepatologie und Transplantationsmedizin

claudia.veltkamp@uk-essen.de0201 723 6311

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026