Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
NCT ID: NCT06072521
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2023-10-31
2024-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy
NCT01113567
Hepatic Metabolism of Galactose and the Galactose Analog FDGal in Patients With Liver Disease and Healthy Subjects
NCT01002261
Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF
NCT04238416
Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy
NCT02022137
Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of N-acetylcysteine Supplementation in Patients With Hepatic and Post Hepatic Jaundice
NCT06236165
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Lactoferrin Bovine
Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.
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.
Lactoferrin Bovine
Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lactoferrin Bovine
Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Grade I and II hepatic encephalopathy.
Exclusion Criteria
* Grade III and IV hepatic encephalopathy.
* Individuals confirmed to be allergic to milk protein
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Al-Azhar University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kholoud El-Sayed Ibrahim
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amin M. Abdel Baki, Doctoral
Role: STUDY_CHAIR
National hepatology and tropical medicine research institute
Nayira A. Abdel Baky, Doctoral
Role: STUDY_DIRECTOR
Al-Azhar University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National hepatology and tropical medicine research institute
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lactoferrin in HE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.