Cirrhosis AlcoholicIGNITENCT07899736
Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
An observational study of Cirrhosis Alcoholic and Fatigue Symptom, run by King's College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis Alcoholic, Fatigue Symptom
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with alcohol-related cirrhosis from the Liver Outpatient Clinical at King's College Hospital
Who may be able to join
- Alcohol related cirrhosis (based on clinical, biochemical, histological and/or radiological parameters)
- Child Pugh class A-B (score 5-9)
- Abstinence from alcohol for a minimum of 6-months
- Capacity to consent
Who cannot join
- 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 malignancy
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- BMI ≥ 35
- Diabetes mellitus (type 1 or type 2)
- HIV, hepatitis B or hepatitis C (HBsAg negative and HCV RNA negative can be included)
- Antibiotics in previous 7 days
- Current rifaximin use
- Current antidepressant use
- Current immunosuppression
- 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 autoimmune 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
About this study
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.
Read more
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.
- Conditions
- Cirrhosis Alcoholic, Fatigue Symptom
- Medical subject headings
- Liver Cirrhosis, Alcoholic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-related cirrhosis with fatigue | Not described | |
| Alcohol-related cirrhosis without fatigue | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating inflammatory marker concentrations
Measured: Baseline (single study visit)
Peripheral blood immune cell phenotypes
Measured: Baseline (single study visit)
Serum-induced changes in human hippocampal neurogenesis
Measured: Following completion of laboratory experiments using serum collected at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis AlcoholicStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899736
- Sponsor's protocol ID
- 376739
- Acronym
- IGNITE
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT07899736
- Acronym / sponsor ID
- IGNITE / 376739
- Conditions
- Cirrhosis Alcoholic, Fatigue Symptom
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol-related cirrhosis with fatigue | – | – |
| Alcohol-related cirrhosis without fatigue | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with alcohol-related cirrhosis from the Liver Outpatient Clinical at King's College Hospital
Key inclusion criteria (4 listed)
- Alcohol related cirrhosis (based on clinical, biochemical, histological and/or radiological parameters)
- Child Pugh class A-B (score 5-9)
- Abstinence from alcohol for a minimum of 6-months
- Capacity to consent
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Circulating inflammatory marker concentrations
Time frame: Baseline (single study visit)
Peripheral blood immune cell phenotypes
Time frame: Baseline (single study visit)
Serum-induced changes in human hippocampal neurogenesis
Time frame: Following completion of laboratory experiments using serum collected at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis Alcoholic and Fatigue Symptom, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating inflammatory marker concentrations (time frame: Baseline (single study visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.