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NOT YET RECRUITING
NCT07899736

Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis

Sponsor: King's College London

View on ClinicalTrials.gov

Summary

Fatigue is a common and debilitating symptom of cirrhosis, the advanced stage of chronic liver disease. Around two-thirds of people with cirrhosis experience fatigue, which can affect their ability to carry out everyday activities and substantially reduce their quality of life. Despite this, the biological causes of fatigue in cirrhosis are poorly understood and there are currently no effective treatments specifically targeting this symptom. Cirrhosis is associated with long-term changes in the immune system, including increased inflammation in the blood. Inflammation in the body can also affect the brain and may alter processes important for normal brain function. We therefore propose that increased inflammation in people with cirrhosis may contribute to the development of fatigue by affecting brain cells. This study will recruit 50 people with stable alcohol-related cirrhosis: 25 experiencing clinically significant fatigue and 25 without clinically significant fatigue. Participants will attend a single study visit, during which information about their fatigue, mood, thinking abilities and liver disease will be collected, alongside a blood sample. We will compare blood samples from participants with and without fatigue to identify differences in inflammation and immune function. We will then use the serum (the liquid component of blood) collected from participants to treat human brain cells grown in the laboratory. This will allow us to investigate whether blood from people experiencing fatigue affects the growth, development and survival of brain cells differently from blood from people without fatigue. By combining measurements in patients with laboratory experiments, we aim to identify biological mechanisms that may contribute to fatigue in cirrhosis. In the longer term, this could identify potential targets for new treatments and improve our understanding and management of this currently undertreated symptom.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2027-01-01

Completion Date

2028-09

Last Updated

2026-10-27

Healthy Volunteers

No