Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Not Applicable

Completed

• Conditions: Minimal Hepatic Encephalopathy; Hepatic Cirrhosis
• Interventions: Dietary Supplement: Hyperproteic and fiber-rich diet; Other: Auxiliary Treatment; Drug: Nitazoxanide

• Registration Number: NCT01135628
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Study Start: 2010-08
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MHE and diet	Hyperproteic and fiber-rich diet	Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.
MHE and diet plus lactobacillus reuteri	Hyperproteic and fiber-rich diet	Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.
MHE and diet plus nitazoxanide	Hyperproteic and fiber-rich diet	Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.
MHE and diet plus lactobacillus reuteri	Auxiliary Treatment	Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.
MHE and diet plus nitazoxanide	Nitazoxanide	Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.

Primary Outcome Measures

Name	Time	Method
Reverse minimal hepatic encephalopathy	6 months	Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy

Secondary Outcome Measures

Name	Time	Method
Prevention of progression	6 months	Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Mexico