NCT01135628

Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Hyperproteic and Fiber-rich Diet Plus Probiotics (Lactobacillus Reuteri) and Nitazoxanide in the Treatment of Minimal Hepatic Encephalopathy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Cirrhosis
• Minimal Hepatic Encephalopathy

Interventions

Type	Name	Description
OTHER	Auxiliary Treatment	Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months
DIETARY_SUPPLEMENT	Hyperproteic and fiber-rich diet	Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
DRUG	Nitazoxanide	Nitazoxanide tablets 400 mg, bid, orally for 6 months

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2010-06-03
• Last updated: 2014-08-20

Locations

1 site across 1 country: Mexico