GELSECTAN® and Covert Hepatic Encephalopathy

Consorci Sanitari de l'Alt Penedès i Garraf

Status: Withdrawn

Conditions: Covert Hepatic Encephalopathy

Treatments: Dietary Supplement: Gelsectan

Study type: Interventional

Funder types: Other

Identifiers

NCT05189834

CSAPG-3

Details and patient eligibility

About

Randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (CHE) will be assigned to take GELSECTAN® (TID) or placebo for 30 days. After a washout period of 15 days, the treatment branches will be interchanged.

The objective of the trial is to obtain pilot variances to design a phase II trial, in which the efficacy of the treatment will be tested. As an exploratory objective, the efficacy of the product in the treatment of covert hepatic encephalopathy will be analyzed.

Main endpoint Improvement in CHE after 30 days of treatment with GELSECTAN®, measured by the Psychometric hepatic encephalopathy score (PHES)

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups

Treatment sequence A

Other group

Description:

Patients will follow the following treatment sequence: 1. Treatment with Gelsectan® (30 days) 2. Washout period (15 days) 3. Treatment with placebo (30 days)

Treatment:

Dietary Supplement: Gelsectan

Treatment sequence B

Other group

Description:

Patients will follow the following treatment sequence: 1. Treatment with placebo (30 days) 2. Washout period (15 days) 3. Treatment with Gelsectan® (30 days)

Treatment:

Dietary Supplement: Gelsectan