Hyperproteic and Fiber-rich Diet Plus Probiotics (Lactobacillus Reuteri) and Nitazoxanide in the Treatment of Minimal Hepatic Encephalopathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reverse minimal hepatic encephalopathy
研究概览
简要总结
Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more, minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a subclinical entity. As so, the investigators propose an auxiliary treatment for the management of such patients with minimal hepatic encephalopathy, using a specific diet consisting on hyperproteic and fibre-rich foods along with two independent interventions, whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic encephalopathy itself to none hepatic encephalopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatic Cirrhosis
- •Minimal hepatic Encephalopathy
排除标准
- •Personal history of surgery in the last 4 weeks
- •Use of neuropsychiatric drugs
- •Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
- •Thyroid disorders without replacement therapy
- •Hepatic or renal transplant
- •Alcoholism with active ingest of alcohol in the last 6 months
- •Pregnancy
- •Labour turn-overs
- •Spontaneous bacterial Peritonitis
- •Personal history of hepatocellular carcinoma
- •Placement of transjugular intrahepatic portosystemic shunt
- •Use of a probiotic in the last 6 months
研究组 & 干预措施
MHE and diet plus lactobacillus reuteri
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.
干预措施: Hyperproteic and fiber-rich diet (Dietary Supplement)
MHE and diet plus lactobacillus reuteri
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.
干预措施: Auxiliary Treatment (Other)
MHE and diet
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.
干预措施: Hyperproteic and fiber-rich diet (Dietary Supplement)
MHE and diet plus nitazoxanide
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.
干预措施: Hyperproteic and fiber-rich diet (Dietary Supplement)
MHE and diet plus nitazoxanide
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.
干预措施: Nitazoxanide (Drug)
结局指标
主要结局
Reverse minimal hepatic encephalopathy
时间窗: 6 months
Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy
次要结局
- Prevention of progression(6 months)
研究者
ALDO TORRE DELGADILLO
M.D. M.Sc
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran