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

Al-Azhar University

Status and phase: Not yet enrolling; Phase 2

Conditions: Hepatic Encephalopathy

Treatments: Drug: Lactoferrin Bovine

Study type: Interventional

Funder types: Other

Identifiers

NCT06072521

Lactoferrin in HE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and older.
• Grade I and II hepatic encephalopathy.

Exclusion criteria

• Pregnant and breastfeeding women.
• Grade III and IV hepatic encephalopathy.
• Individuals confirmed to be allergic to milk protein

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Lactoferrin bovine once a day

Active Comparator group

Description:

15 patients will be subjected to take 100mg of lactoferrin bovine in the form of sachets twice per day for 15 days.

Treatment:

Drug: Lactoferrin Bovine

Lactoferrin bovine twice a day

Active Comparator group

Description:

15 patients will be subjected to take 100mg of lactoferrin bovine in the form of sachets once per day for 15 days.

Treatment:

Drug: Lactoferrin Bovine

Control group

No Intervention group

Description:

15 patients will be subjected to take only the standard treatment regimen that is applied at the National hepatology and tropical medicine research institute in Egypt.