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Not yet recruitingNCT07899736IGNITEUpdated Oct 27, 2026

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

An observational study in Cirrhosis Alcoholic and Fatigue Symptom, sponsored by King's College London. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by King's College London · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cirrhosis Alcoholic
  • Fatigue Symptom
03

In context

Liver Cirrhosis, Alcoholic

44 studies on the registry are indexed under Liver Cirrhosis, Alcoholic; 13 are open to participants now.

This study's planned enrollment of 50 is below the median of 142 across 19 observational studies indexed under Liver Cirrhosis, Alcoholic.

Browse Liver Cirrhosis, Alcoholic studies →

Lead sponsor

King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with alcohol-related cirrhosis from the Liver Outpatient Clinical at King's College Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Alcohol related cirrhosis (based on clinical, biochemical, histological and/or radiological parameters)
  • class A-B (score 5-9)
  • Abstinence from alcohol for a minimum of 6-months
  • Capacity to consent

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or acute-on-chronic liver failure (ACLF) in previous 14 days
  • Current overt hepatic encephalopathy (West Haven grade ≥ 2)
  • Liver transplant
  • Active
  • ≥ 35
  • Diabetes mellitus (type 1 or type 2)
  • , or (HBsAg negative and HCV RNA negative can be included)
  • Antibiotics in previous 7 days
  • Current rifaximin use
  • Current antidepressant use
  • Current
  • Current use of benozodiazepines or other GABAergic drugs
  • Current use of opioids
  • Diagnosis of concurrent primary medical disorder defined by fatigue as a key symptom including chronic fatigue syndrome, fibromyalgia, post-viral fatigue syndrome, long COVID and diseases such as systemic lupus erythematosus and rheumatoid arthritis.
  • Diagnosis of severe major depressive disorder or other major neuropsychiatric disorder
  • Patients who have a medical condition, or relevant psychological, familial, or social factor that may jeopardise their health, compliance, or influence the trial integrity
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Alcohol-related cirrhosis with fatigue
  • Alcohol-related cirrhosis without fatigue
06

What researchers measure

Primary outcomes

  1. Circulating inflammatory marker concentrations

    Time frame: Baseline (single study visit)

  2. Peripheral blood immune cell phenotypes

    Time frame: Baseline (single study visit)

  3. Serum-induced changes in human hippocampal neurogenesis

    Time frame: Following completion of laboratory experiments using serum collected at baseline

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07899736
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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