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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05189834
Other study ID # CSAPG-3
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 11, 2022
Est. completion date July 30, 2022

Study information

Verified date February 2024
Source Consorci Sanitari de l'Alt Penedès i Garraf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Intervention

Dietary Supplement:
Gelsectan
Xyloglucan, vegetable protein and xylooligosaccharides

Locations

Country Name City State
Spain Consorci Sanitari Alt'Pènedes i Garraf Barcelona Cataluña

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06367127 - Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Completed NCT03077217 - Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy Phase 4
Completed NCT03585257 - HEAL STUDY (Hepatic Encephalopathy and Albumin Study) Phase 2