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

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06072521
• Other study ID #: Lactoferrin in HE
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Al-Azhar University
• Contact: Kholoud E. Ibrahim, Bachelor
• Phone: +20 01066645179
• Email: Khloud_elsayed[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• Lactoferrin Bovine
Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.

Locations

Country	Name	City	State
Egypt	National hepatology and tropical medicine research institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bajaj JS. Hepatic encephalopathy: classification and treatment. J Hepatol. 2018 Apr;68(4):838-839. doi: 10.1016/j.jhep.2017.11.005. No abstract available. — View Citation

Elsaid MI, Rustgi VK. Epidemiology of Hepatic Encephalopathy. Clin Liver Dis. 2020 May;24(2):157-174. doi: 10.1016/j.cld.2020.01.001. Epub 2020 Mar 2. — View Citation

Patidar KR, Bajaj JS. Covert and Overt Hepatic Encephalopathy: Diagnosis and Management. Clin Gastroenterol Hepatol. 2015 Nov;13(12):2048-61. doi: 10.1016/j.cgh.2015.06.039. Epub 2015 Jul 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum concentration of inflammatory cytokines	Change in serum concentration of inflammatory cytokine Tumor necrosis factor-alpha (TNF-a) (pg/ml)	15 days
Primary	Change in serum concentration of Nuclear factor kB	Change in serum concentration of Nuclear factor kB (NFkB) (ng/ml)	15 days
Primary	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)	15 days
Secondary	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.	15 days
Secondary	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.	15 days
Secondary	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.	15 days
Secondary	Length of hospital stay	Length of hospital stay	15 days
Secondary	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.	15 days
Secondary	Number of patients transferred to ICU	Number of patients transferred to ICU	15 days