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.

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Cirrhosis; Minimal Hepatic Encephalopathy
• Intervention / Treatment: Other: Auxiliary Treatment; Dietary supplement: Hyperproteic and fiber-rich diet; Drug: Nitazoxanide

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14000
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: MHE and diet plus lactobacillus reuteri; Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.	Other: Auxiliary Treatment; Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months; Other Names: Probiotics; Biogaia; Dietary supplement: Hyperproteic and fiber-rich diet; Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
ACTIVE_COMPARATOR: MHE and diet; Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.	Dietary supplement: Hyperproteic and fiber-rich diet; Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
ACTIVE_COMPARATOR: MHE and diet plus nitazoxanide; Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reverse minimal hepatic encephalopathy	Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy	3 months
Reverse minimal hepatic encephalopathy	Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of progression	Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.	3 months
Prevention of progression	Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy	6 months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Investigators: Principal Investigator: Aldo Torre-Delgadillo, MD, Instituto Nacional de Ciencias Medicas de Nutricion

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (ESTIMATE): June 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Minimal hepatic encephalopathy; Lactobacillus reuteri; Hepatic cirrhosis; Psychometric Hepatic Encephalopathy Score (PHES); Hyperproteic and fiber-rich diet; Critical Flicker Frequency (CFF)
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Fibrosis; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Anti-Infective Agents; Antiparasitic Agents; Nitazoxanide
• Other Study ID Numbers: GAS-83-09/10-1