Back to resultsGELSECTAN® and Covert Hepatic Encephalopathy (GELSECTAN)
Primary Purpose
Covert Hepatic Encephalopathy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gelsectan
Sponsored by
About this trial
This is an interventional treatment trial for Covert Hepatic Encephalopathy focused on measuring Covert Hepatic Encephalopathy, Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 85 years.
- Liver cirrhosis defined by a previous liver biopsy or by clinical data.
- Presence of minimal hepatic encephalopathy (MHE) defined by two psychometric methods (PHES and / or S-ANT and / or Sloop-test).
- Adequately informed patients who grant their written consent to participate in the study.
Exclusion Criteria:
- Alternative neurological diagnosis.
- Hepatic encephalopathy stage ≥2 using the adapted West-Haven scale.
- Terminal disease. At the discretion of the doctor, where the patient is in an irreversible situation, in which hepatic encephalopathy is a final manifestation.
- Presence of Acute-on-chronic liver failure defined by the presence of decompensated liver cirrhosis with severe organ or multi-organ failure.
- MELD score greater than 25 at the time of inclusion.
- Hospitalization for any reason.
- 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).
- Active digestive bleeding. Before inclusion, there must have been a 48-hour period without signs of bleeding.
- Patients with hypersensitivity or allergy to any of the components of GELSECTAN® (grape, pea).
- Clinical situations in which the administration of oral feeding is contraindicated.
- Active oncological processes, including hepatocarcinoma.
- Active infection of any origin.
- Acute renal failure (AKI). Defined by the current diagnostic criteria of the KDIGO group (Kidney Disease Improving Global Outcomes).
- Dehydration Diagnosed by physical examination of the patient.
- Severe hyponatremia. Defined by plasma sodium <130 mEq / dl.
- Concomitant use of sedative drugs, such as benzodiazepines, morphic or derivatives (methadone, tramadol ...)
- 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.
- Consumption of drugs currently indicated for the treatment of HE: Lactulose, lactitol and antibiotics.
- Participation in another clinical trial
Sites / Locations
- Consorci Sanitari Alt'Pènedes i Garraf
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Treatment sequence A
Treatment sequence B
Arm Description
Patients will follow the following treatment sequence: Treatment with Gelsectan® (30 days) Washout period (15 days) Treatment with placebo (30 days)
Patients will follow the following treatment sequence: Treatment with placebo (30 days) Washout period (15 days) Treatment with Gelsectan® (30 days)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05189834
First Posted
December 28, 2021
Last Updated
March 9, 2022
Sponsor
Consorci Sanitari de l'Alt Penedès i Garraf
1. Study Identification
Unique Protocol Identification Number
NCT05189834
Brief Title
GELSECTAN® and Covert Hepatic Encephalopathy
Acronym
GELSECTAN
Official Title
Effects of GELSECTAN® Administration on Covert Hepatic Encephalopathy (CHE) in Patients With Cirrhosis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 11, 2022 (Anticipated)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consorci Sanitari de l'Alt Penedès i Garraf
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covert Hepatic Encephalopathy
Keywords
Covert Hepatic Encephalopathy, Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment sequence A
Arm Type
Other
Arm Description
Patients will follow the following treatment sequence:
Treatment with Gelsectan® (30 days)
Washout period (15 days)
Treatment with placebo (30 days)
Arm Title
Treatment sequence B
Arm Type
Other
Arm Description
Patients will follow the following treatment sequence:
Treatment with placebo (30 days)
Washout period (15 days)
Treatment with Gelsectan® (30 days)
Intervention Type
Dietary Supplement
Intervention Name(s)
Gelsectan
Intervention Description
Xyloglucan, vegetable protein and xylooligosaccharides
Primary Outcome Measure Information:
Title
Covert Hepatic Encephalopathy change
Description
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
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 85 years.
Liver cirrhosis defined by a previous liver biopsy or by clinical data.
Presence of minimal hepatic encephalopathy (MHE) defined by two psychometric methods (PHES and / or S-ANT and / or Sloop-test).
Adequately informed patients who grant their written consent to participate in the study.
Exclusion Criteria:
Alternative neurological diagnosis.
Hepatic encephalopathy stage ≥2 using the adapted West-Haven scale.
Terminal disease. At the discretion of the doctor, where the patient is in an irreversible situation, in which hepatic encephalopathy is a final manifestation.
Presence of Acute-on-chronic liver failure defined by the presence of decompensated liver cirrhosis with severe organ or multi-organ failure.
MELD score greater than 25 at the time of inclusion.
Hospitalization for any reason.
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).
Active digestive bleeding. Before inclusion, there must have been a 48-hour period without signs of bleeding.
Patients with hypersensitivity or allergy to any of the components of GELSECTAN® (grape, pea).
Clinical situations in which the administration of oral feeding is contraindicated.
Active oncological processes, including hepatocarcinoma.
Active infection of any origin.
Acute renal failure (AKI). Defined by the current diagnostic criteria of the KDIGO group (Kidney Disease Improving Global Outcomes).
Dehydration Diagnosed by physical examination of the patient.
Severe hyponatremia. Defined by plasma sodium <130 mEq / dl.
Concomitant use of sedative drugs, such as benzodiazepines, morphic or derivatives (methadone, tramadol ...)
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.
Consumption of drugs currently indicated for the treatment of HE: Lactulose, lactitol and antibiotics.
Participation in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Albertos, PhD
Phone
938 96 00 25
Email
salbertos@csg.cat
Facility Information:
Facility Name
Consorci Sanitari Alt'Pènedes i Garraf
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08810
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Albertos
Phone
938 96 00 25
Email
salbertos@csg.cat
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
GELSECTAN® and Covert Hepatic Encephalopathy
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