An interventional study of Auxiliary Treatment and Hyperproteic and fiber-rich diet in Hepatic Cirrhosis and Minimal Hepatic Encephalopathy, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Completed at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-08-20.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Not applicable, Interventional, and Treatment
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.
1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 1,003 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 144 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.
Other: Auxiliary Treatment · Dietary Supplement: Hyperproteic and fiber-rich diet
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.
Dietary Supplement: Hyperproteic and fiber-rich diet
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.
Dietary Supplement: Hyperproteic and fiber-rich diet · Drug: Nitazoxanide
Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months
Also known as: Biogaia, Probiotics
Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
Nitazoxanide tablets 400 mg, bid, orally for 6 months
Reverse minimal hepatic encephalopathy
Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy
Time frame: 3 months
Reverse minimal hepatic encephalopathy
Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy
Time frame: 6 months
Prevention of progression
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.
Time frame: 3 months
Prevention of progression
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy
Time frame: 6 months
The record gives a start of Aug 2010, a primary completion of May 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitazoxanide
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