Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in serum concentration of inflammatory cytokines
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older.
- •Grade I and II hepatic encephalopathy.
排除标准
- •Pregnant and breastfeeding women.
- •Grade III and IV hepatic encephalopathy.
- •Individuals confirmed to be allergic to milk protein
研究组 & 干预措施
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.
干预措施: Lactoferrin Bovine (Drug)
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.
干预措施: Lactoferrin Bovine (Drug)
结局指标
主要结局
Change in serum concentration of inflammatory cytokines
时间窗: 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
时间窗: 15 days
Change in serum concentration of Nuclear factor kB (NFkB) (ng/ml)
Change in serum concentration of oxidative stress markers
时间窗: 15 days
Change in serum concentration of oxidative stress markers Malondialdehyde (MDA) (n.mol/mg/protein) and Glutathione (GSH) (m.mol/mg/protein)
次要结局
- 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)
- Number of patients transferred to ICU(15 days)
研究者
Kholoud El-Sayed Ibrahim
Principal investigator
Al-Azhar University