Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT05189834
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 85 years.
2. Liver cirrhosis defined by a previous liver biopsy or by clinical data.
3. Presence of minimal hepatic encephalopathy (MHE) defined by two psychometric methods (PHES and / or S-ANT and / or Sloop-test).
4. Adequately informed patients who grant their written consent to participate in the study.
Exclusion Criteria:
1. Alternative neurological diagnosis.
2. Hepatic encephalopathy stage ≥2 using the adapted West-Haven scale.
3. Terminal disease. At the discretion of the doctor, where the patient is in an irreversible situation, in which hepatic encephalopathy is a final manifestation.
4. Presence of Acute-on-chronic liver failure defined by the presence of decompensated liver cirrhosis with severe organ or multi-organ failure.
5. MELD score greater than 25 at the time of inclusion.
6. Hospitalization for any reason.
7. Neurological or psychiatric comorbidity that makes the evaluation of hepatic encephalopathy difficult. This includes patients with mental illnesses (dementia, cerebrovascular disease with sequelae, Parkinson's disease, schizophrenia).
8. Active digestive bleeding. Before inclusion, there must have been a 48-hour period without signs of bleeding.
9. Patients with hypersensitivity or allergy to any of the components of GELSECTAN® (grape, pea).
10. Clinical situations in which the administration of oral feeding is contraindicated.
11. Active oncological processes, including hepatocarcinoma.
12. Active infection of any origin.
13. Acute renal failure (AKI). Defined by the current diagnostic criteria of the KDIGO group (Kidney Disease Improving Global Outcomes).
14. Dehydration Diagnosed by physical examination of the patient.
15. Severe hyponatremia. Defined by plasma sodium \<130 mEq / dl.
16. Concomitant use of sedative drugs, such as benzodiazepines, morphic or derivatives (methadone, tramadol ...)
17. Active drug and/or alcohol use. In each case of clinical suspicion of drug use, an analysis of toxins in urine will be carried out, which includes cocaine, cannabis, opiates. All patients with confirmed alcohol consumption greater than 3 UBD in men or 2 UBD in women will be excluded.
18. Consumption of drugs currently indicated for the treatment of HE: Lactulose, lactitol and antibiotics.
19. Participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05189834
Study Brief:
Protocol Section:
NCT05189834