NCT06072521

Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of lactoferrin as an adjunct therapy in improving clinical symptoms and laboratory indices in individuals with hepatic encephalopathy.

Detailed description

Nonabsorbable disaccharides, such as lactulose or lactitol, decrease the absorption of ammonia and are considered a first-line treatment for hepatic encephalopathy. Antimicrobial therapy also is a part of treatment regimen to alter the gut microbiota to create a more favorable microbiome that results in lower endogenous bacterial production of ammonia and Rifaximin is now the preferred antimicrobial agent for the treatment of hepatic encephalopathy. Many researchers have focused on identifying promising therapeutics and prebiotics in the hope of improving the treatment of hepatic encephalopathy, therefore there is a need to add an adjuvant therapy to decrease oxidative stress and pro-inflammatory cytokines.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Lactoferrin Bovine	Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2023-10-10
• Last updated: 2023-10-17

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study