Hepatic EncephalopathyPhase 2NCT06072521
Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
A Phase 2 study testing Lactoferrin Bovine in people with Hepatic Encephalopathy, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Lactoferrin Bovine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2023to Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older.
- Grade I and II hepatic encephalopathy.
Who cannot join
- Pregnant and breastfeeding women.
- Grade III and IV hepatic encephalopathy.
- Individuals confirmed to be allergic to milk protein
Trial locations and contacts
1 site in 1 country.
Egypt1 site
National hepatology and tropical medicine research institute
Cairo
Amin M. Abdel Baki, Physician, +02 01014502029, dr_amin114@yahoo.com
Amin M. Abdel Baki, Physician
About this study
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.
Read the 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.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Lactoferrin Bovine
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin BovineDrug
Also called Pravotin sachets 100 mg
Lactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum concentration of inflammatory cytokines
Change in serum concentration of inflammatory cytokine Tumor necrosis factor-alpha (TNF-a) (pg/ml)
Measured: 15 days
Change in serum concentration of Nuclear factor kB
Change in serum concentration of Nuclear factor kB (NFkB) (ng/ml)
Measured: 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)
Measured: 15 days
Secondary outcomes (6)
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.
Measured: 15 days
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.
Measured: 15 days
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.
Measured: 15 days
Length of hospital stay
Length of hospital stay
Measured: 15 days
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.
Measured: 15 days
Number of patients transferred to ICU
Number of patients transferred to ICU
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud El-Sayed Ibrahim, Al-Azhar University
- Investigators
- Amin M. Abdel Baki, Doctoral, Study chair, National hepatology and tropical medicine research instituteNayira A. Abdel Baky, Doctoral, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072521
- Sponsor's protocol ID
- Lactoferrin in HE
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29756596Patidar 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.
PubMed 26164219Elsaid 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.
PubMed 32245524
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT06072521
- Acronym / sponsor ID
- Lactoferrin in HE
- Conditions
- Hepatic Encephalopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin bovine once a day | Active comparator | Drug: Lactoferrin Bovine15 patients will be subjected to take 100mg of lactoferrin bovine in the form of sachets twice per day for 15 days. |
| Lactoferrin bovine twice a day | Active comparator | Drug: Lactoferrin Bovine15 patients will be subjected to take 100mg of lactoferrin bovine in the form of sachets once per day for 15 days. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older.
- Grade I and II hepatic encephalopathy.
Key exclusion criteria (3 listed)
- Pregnant and breastfeeding women.
- Grade III and IV hepatic encephalopathy.
- Individuals confirmed to be allergic to milk protein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin BovineAlso: Pravotin sachets 100 mgLactoferrin bovine with concentration 100 mg will be given to the patients in test groups in the form of sachets. | Drug | Lactoferrin bovine once a day, Lactoferrin bovine twice a day |
Primary outcome
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)
Change in serum concentration of Nuclear factor kB
Time frame: 15 days
Change in serum concentration of Nuclear factor kB (NFkB) (ng/ml)
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)
6 secondary outcomes
Change in Psychometric Hepatic Encephalopathy Score (PHES)
Time frame: 15 days
Change in Psychometric Hepatic Encephalopathy Score (PHES)
Time frame: 15 days
Change in Psychometric Hepatic Encephalopathy Score (PHES)
Time frame: 15 days
Length of hospital stay
Time frame: 15 days
The rate of adverse events occurring during the treatment
Time frame: 15 days
Number of patients transferred to ICU
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 29756596Bajaj 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.
- Background: PubMed 26164219Patidar 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.
- Background: PubMed 32245524Elsaid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amin M. Abdel Baki, Doctoral study chair
National hepatology and tropical medicine research institute
Nayira A. Abdel Baky, Doctoral study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactoferrin Bovine in people with Hepatic Encephalopathy, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kholoud E. Ibrahim, Bachelor (+20 01066645179, Khloud_elsayed@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum concentration of inflammatory cytokines (time frame: 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072521, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.