NCT05189834

GELSECTAN® and Covert Hepatic Encephalopathy

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Covert Hepatic Encephalopathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gelsectan	Xyloglucan, vegetable protein and xylooligosaccharides

Timeline

• Start date: 2022-03-11
• Primary completion: 2022-05-30
• Completion: 2022-07-30
• First posted: 2022-01-13
• Last updated: 2024-02-28

Locations

1 site across 1 country: Spain