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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
45
Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.
National hepatology and tropical medicine research institute
Cairo, Egypt
Change in serum concentration of inflammatory cytokines
Change in serum concentration of inflammatory cytokine Tumor necrosis factor-alpha (TNF-a) (pg/ml)
Time frame: 15 days
Change in serum concentration of Nuclear factor kB
Change in serum concentration of Nuclear factor kB (NFkB) (ng/ml)
Time frame: 15 days
Change in serum concentration of oxidative stress markers
Change in serum concentration of oxidative stress markers Malondialdehyde (MDA) (n.mol/mg/protein) and Glutathione (GSH) (m.mol/mg/protein)
Time frame: 15 days
Change in Psychometric Hepatic Encephalopathy Score (PHES)
Number connection test A (NCT-A) - in this test the numbers have to be joined consecutively in ascending numerical order (1, 2, 3…) as quickly as possible.
Time frame: 15 days
Change in Psychometric Hepatic Encephalopathy Score (PHES)
Digit symbol test (DST) - in this test the patient is given a series of double-boxes with a number given in the upper part. The task is to draw a symbol pertinent to this number into the lower part of the boxes. Nine fixed pairs of numbers and symbols are given at the top of the test sheet. Test result is the number of boxes correctly filled within 90 seconds.
Time frame: 15 days
Change in Psychometric Hepatic Encephalopathy Score (PHES)
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.
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Time frame: 15 days
Length of hospital stay
Length of hospital stay
Time frame: 15 days
The rate of adverse events occurring during the treatment
Number of patients who experienced adverse events such as diarrhea, rash, loss of appetite, fatigue, and constipation.
Time frame: 15 days
Number of patients transferred to ICU
Number of patients transferred to ICU
Time frame: 15 days