drugset / Trial / NCT01135628

Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

NCT01135628

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-08
Primary completion
2014-05
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitazoxanide Other / unclassified 400 mg Oral