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

Phase 2

Not yet recruiting

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Lactoferrin Bovine

• Registration Number: NCT06072521
• Lead Sponsor: Al-Azhar University

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-21
• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-10
• Last Update Submitted: 2023-10-14
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactoferrin bovine once a day	Lactoferrin Bovine	15 patients will be subjected to take 100mg of lactoferrin bovine in the form of sachets twice per day for 15 days.
Lactoferrin bovine twice a day	Lactoferrin Bovine	15 patients will be subjected to take 100mg of lactoferrin bovine in the form of sachets once per day for 15 days.

Primary Outcome Measures

Name	Time	Method
Change in serum concentration of inflammatory cytokines	15 days	Change in serum concentration of inflammatory cytokine Tumor necrosis factor-alpha (TNF-a) (pg/ml)
Change in serum concentration of Nuclear factor kB	15 days	Change in serum concentration of Nuclear factor kB (NFkB) (ng/ml)
Change in serum concentration of oxidative stress markers	15 days	Change in serum concentration of oxidative stress markers Malondialdehyde (MDA) (n.mol/mg/protein) and Glutathione (GSH) (m.mol/mg/protein)

Secondary Outcome Measures

Name	Time	Method
Change in Psychometric Hepatic Encephalopathy Score (PHES)	15 days	Simplified animal naming test (S-ANT) - in this test patients are asked to name as many animals as possible in one minute. Repeats and errors were excluded from the calculation. The number of named animals after one minute was the definitive score.
Length of hospital stay	15 days	Length of hospital stay
The rate of adverse events occurring during the treatment	15 days	Number of patients who experienced adverse events such as diarrhea, rash, loss of appetite, fatigue, and constipation.
Number of patients transferred to ICU	15 days	Number of patients transferred to ICU

Trial Locations

Locations (1)

National hepatology and tropical medicine research institute; 🇪🇬 Cairo, Egypt