Clinical trial NCT06072521: Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
Official title: Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hepatic Encephalopathy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum concentration of inflammatory cytokines
timeFrame: 15 days
measure: Change in serum concentration of Nuclear factor kB
timeFrame: 15 days
measure: Change in serum concentration of oxidative stress markers
timeFrame: 15 days
Secondary outcomes:
measure: Change in Psychometric Hepatic Encephalopathy Score (PHES)
timeFrame: 15 days
measure: Change in Psychometric Hepatic Encephalopathy Score (PHES)
timeFrame: 15 days
measure: Change in Psychometric Hepatic Encephalopathy Score (PHES)
timeFrame: 15 days
measure: Length of hospital stay
timeFrame: 15 days
measure: The rate of adverse events occurring during the treatment
timeFrame: 15 days
measure: Number of patients transferred to ICU
timeFrame: 15 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National hepatology and tropical medicine research institute
Study officials:
affiliation: National hepatology and tropical medicine research institute
name: Amin M. Abdel Baki, Doctoral
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Nayira A. Abdel Baky, Doctoral
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.