GELSECTAN® and Covert Hepatic Encephalopathy (GELSECTAN)

Effects of GELSECTAN® Administration on Covert Hepatic Encephalopathy (CHE) in Patients With Cirrhosis.

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)

Study Overview

• Status: Withdrawn
• Conditions: Covert Hepatic Encephalopathy
• Intervention / Treatment: Dietary supplement: Gelsectan

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonia Albertos, PhD; Phone Number: 938 96 00 25; Email: salbertos@csg.cat

Study Locations

• Spain
  • Cataluña
    • Barcelona, Cataluña, Spain, 08810
      • Consorci Sanitari Alt'Pènedes i Garraf
      • Contact: Sonia Albertos; Phone Number: 938 96 00 25; Email: salbertos@csg.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment sequence A; Patients will follow the following treatment sequence: Treatment with Gelsectan® (30 days); Washout period (15 days); Treatment with placebo (30 days)	Dietary supplement: Gelsectan; Xyloglucan, vegetable protein and xylooligosaccharides
Other: Treatment sequence B; Patients will follow the following treatment sequence: Treatment with placebo (30 days); Washout period (15 days); Treatment with Gelsectan® (30 days)	Dietary supplement: Gelsectan; Xyloglucan, vegetable protein and xylooligosaccharides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Covert Hepatic Encephalopathy change	Covert Hepatic Encephalopathy change after 30 days of treatment with GELSECTAN®, by means of the Psychometric hepatic encephalopathy score (PHES), being patients classified as having MHE when their PHES is less than -4	30 days

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

Study record dates

Study Major Dates

• Study Start (Estimated): March 11, 2022
• Primary Completion (Estimated): May 30, 2022
• Study Completion (Estimated): July 30, 2022

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cirrhosis; Covert Hepatic Encephalopathy
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: CSAPG-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No