Hepatic Cirrhosis | Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy
Hepatic Cirrhosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Hepatic Cirrhosis - Minimal hepatic Encephalopathy Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Minimal Hepatic Encephalopathy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Auxiliary TreatmentLactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months
Dietary Supplement:Hyperproteic and fiber-rich dietHyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
Drug:NitazoxanideNitazoxanide tablets 400 mg, bid, orally for 6 months
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MHE and diet plus lactobacillus reuteriPatients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.
MHE and dietPatients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.
MHE and diet plus nitazoxanidePatients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.
Start Date: August 2010
Completed Date: July 2014
Primary Outcome: Reverse minimal hepatic encephalopathy
Secondary Outcome: Prevention of progression
Study sponsors, principal investigator, and references
Principal Investigator: Aldo Torre-Delgadillo, MD
Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran