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

October 14, 2023 updated by: Kholoud El-Sayed Ibrahim, Al-Azhar University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • National Hepatology and Tropical Medicine Research Institute
        • Contact:
        • Principal Investigator:
          • Amin M. Abdel Baki, Physician
        • Sub-Investigator:
          • Kholoud E. Ibrahim, Pharmacist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum concentration of inflammatory cytokines
Time Frame: 15 days
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
Time Frame: 15 days
Change in serum concentration of Nuclear factor kB (NFkB) (ng/ml)
15 days
Change in serum concentration of oxidative stress markers
Time Frame: 15 days
Change in serum concentration of oxidative stress markers Malondialdehyde (MDA) (n.mol/mg/protein) and Glutathione (GSH) (m.mol/mg/protein)
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Psychometric Hepatic Encephalopathy Score (PHES)
Time Frame: 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.
15 days
Change in Psychometric Hepatic Encephalopathy Score (PHES)
Time Frame: 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.
15 days
Change in Psychometric Hepatic Encephalopathy Score (PHES)
Time Frame: 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.
15 days
Length of hospital stay
Time Frame: 15 days
Length of hospital stay
15 days
The rate of adverse events occurring during the treatment
Time Frame: 15 days
Number of patients who experienced adverse events such as diarrhea, rash, loss of appetite, fatigue, and constipation.
15 days
Number of patients transferred to ICU
Time Frame: 15 days
Number of patients transferred to ICU
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lactoferrin in HE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe