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Study identifier: NCT07161245 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis

Condition: Primary Biliary Cholangitis (PBC)  ·  Sponsor: Hospital Clinic of Barcelona

PhaseNA
Planned participants64
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersYes

About this study

The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients with primary biliary cholangitis. Consequently, this improvement is anticipated to enhance quality of life and cognitive symptoms, while also positively impacting emotional, social, and occupational aspects. From a pathophysiological perspective, it is hypothesized that chronic cholestasis and/or immune system activation, with the release of pro-inflammatory cytokines, leads to both central and peripheral alterations causing fatigue. At the central level, systemic inflammation may induce neuronal senescence in the basal ganglia, resulting in altered functional connectivity networks dependent on these regions and/or structural and connectivity changes in areas involved in interoception, such as the insula and anterior cingulate cortex. At the peripheral level, the hypothesis is that chronic inflammation mediated by anti-mitochondrial antibodies causes mitochondrial metabolic dysfunction in muscle cells, which would be reflected in changes observed in the gene expression analysis of these cells. Improvement in fatigue following the multimodal intervention program is expected to be associated with normalization of the immunological profile, enhanced functional brain connectivity, and improved mitochondrial metabolism in muscle.

This description comes directly from the study's public registry record.

Talk to the study team

Helena Hernández Évole, MD  ·  +34 932 27 54 00  ·  HEHERNANDEZ@clinic.cat

Sergio Rodríguez Tajes, MD, PhD  ·  SRODRIGUEZ@CLINIC.CAT

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital Clinic de BarcelonaBarcelona, Barcelona, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT07161245