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

• Sponsor: Al-Azhar University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06072521
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy	Drug: Lactoferrin Bovine	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lactoferrin bovine once a day 15 patients will be subjected to take 100mg of lactoferrin bovine in the form of sachets twice per day for 15 days.	Drug: Lactoferrin Bovine; Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.; Other Names: Pravotin sachets 100 mg
Active Comparator: Lactoferrin bovine twice a day 15 patients will be subjected to take 100mg of lactoferrin bovine in the form of sachets once per day for 15 days.	Drug: Lactoferrin Bovine; Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.; Other Names: Pravotin sachets 100 mg
No Intervention: Control group 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.

Outcome Measures

Primary Outcome Measures

1. Change in serum concentration of inflammatory cytokines [15 days]

   Change in serum concentration of inflammatory cytokine Tumor necrosis factor-alpha (TNF-a) (pg/ml)

2. Change in serum concentration of Nuclear factor kB [15 days]

   Change in serum concentration of Nuclear factor kB (NFkB) (ng/ml)

3. 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

1. 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.

2. Change in Psychometric Hepatic Encephalopathy Score (PHES) [15 days]

   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.

3. 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.

4. Length of hospital stay [15 days]

   Length of hospital stay

5. 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.

6. Number of patients transferred to ICU [15 days]

   Number of patients transferred to ICU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National hepatology and tropical medicine research institute	Cairo		Egypt

Sponsors and Collaborators

• Al-Azhar University

Investigators

• Study Chair: Amin M. Abdel Baki, Doctoral, National hepatology and tropical medicine research institute
• Study Director: Nayira A. Abdel Baky, Doctoral, Al-Azhar University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Kholoud El-Sayed Ibrahim, Principal investigator, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT06072521
• Other Study ID Numbers: Lactoferrin in HE
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 17, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Hepatic Encephalopathy; Brain Diseases; Lactoferrin

Study Results

No Results Posted as of Oct 17, 2023