Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

NCT01135628 | Completed

• 1 other identifier: GAS-83-09/10-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Cirrhosis; Minimal Hepatic Encephalopathy

Keywords

Hepatic cirrhosis; Minimal hepatic encephalopathy; Hyperproteic and fiber-rich diet; Lactobacillus reuteri; Psychometric Hepatic Encephalopathy Score (PHES); Critical Flicker Frequency (CFF)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Prevention of progression

  3 months

• Prevention of progression

  6 months

Study Arms (3)

MHE and diet plus lactobacillus reuteri

ACTIVE COMPARATOR

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

MHE and diet

ACTIVE COMPARATOR

Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.

Dietary Supplement: Hyperproteic and fiber-rich diet

MHE and diet plus nitazoxanide

ACTIVE COMPARATOR

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

Interventions

Auxiliary Treatment OTHER

Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months

Also known as: Biogaia, Probiotics

MHE and diet plus lactobacillus reuteri

Hyperproteic and fiber-rich diet DIETARY_SUPPLEMENT

Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet

MHE and diet; MHE and diet plus lactobacillus reuteri; MHE and diet plus nitazoxanide

Nitazoxanide DRUG

Nitazoxanide tablets 400 mg, bid, orally for 6 months

MHE and diet plus nitazoxanide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatic Cirrhosis
• Minimal hepatic Encephalopathy

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Probiotics; nitazoxanide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Aldo Torre-Delgadillo, MD

  Instituto Nacional de Ciencias Medicas de Nutricion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. M.Sc

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 3, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

ME (1)