Hepatic Encephalopathy
Conditions
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.
Interventions
Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
It is a randomized controlled clinical trial (Pilot study) that will be conducted on hepatic encephalopathy patients who will attend to National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt to receive the treatment regimen in concurrence with the Egyptian guidelines of treatment. Eligible patients will randomly assigned in a 1:1:1 ratio to receive lactoferrin (Pravotin@ sachets) as followings: Group I: Patients receive standard care alone (control group) Group II: Patients receive 100mg lactoferrin orally (one sachet (100 mg), one time a day) plus standard care. Group III: Patients receive 200 mg lactoferrin orally (one sachet (100mg), two times a day) plus standard care. Lactoferrin will be administrated in groups II and III for 15 days. The blood samples of all eligible participants and reported signs and symptoms will be collected after 15 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychometric Hepatic Encephalopathy Score (PHES) | 15 days | 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. |
| Number of patients transferred to ICU | 15 days | Number of patients transferred to ICU |
| 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. |
Countries
Egypt
Contacts
Primary ContactKholoud E. Ibrahim, Bachelor
Backup ContactGellan A. Mohamed, Doctoral
Outcome results
None listed