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

NCT06072521 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Lactoferrin in HE
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (3)

• Change in serum concentration of inflammatory cytokines

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

  15 days

• Change in serum concentration of Nuclear factor kB

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

  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)

  15 days

Secondary Outcomes (6)

• Change in Psychometric Hepatic Encephalopathy Score (PHES)

  15 days

• Change in Psychometric Hepatic Encephalopathy Score (PHES)

  15 days

• Change in Psychometric Hepatic Encephalopathy Score (PHES)

  15 days

• Length of hospital stay

  15 days

• The rate of adverse events occurring during the treatment

  15 days

Study Arms (3)

Lactoferrin bovine once a day

ACTIVE COMPARATOR

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 twice a day

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

Lactoferrin Bovine DRUG

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

Also known as: Pravotin sachets 100 mg

Lactoferrin bovine once a day; Lactoferrin bovine twice a day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older.
• Grade I and II hepatic encephalopathy.

You may not qualify if:

• Pregnant and breastfeeding women.
• Grade III and IV hepatic encephalopathy.
• Individuals confirmed to be allergic to milk protein

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

National hepatology and tropical medicine research institute

Cairo, Egypt

Location

Related 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.

  PMID: 29756596 BACKGROUND

• 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.

  PMID: 26164219 BACKGROUND

• 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.

  PMID: 32245524 BACKGROUND

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Amin M. Abdel Baki, Doctoral

  National hepatology and tropical medicine research institute

  STUDY CHAIR

• Nayira A. Abdel Baky, Doctoral

  Al-Azhar University

  STUDY DIRECTOR

Central Study Contacts

Kholoud E. Ibrahim, Bachelor

CONTACT

+20 01066645179; Khloud_elsayed@azhar.edu.eg

Gellan A. Mohamed, Doctoral

CONTACT

+20 01062602678; gelan.alaa@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)