Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Hepatic Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135628
• Other study ID #: GAS-83-09/10-1
• Status: Completed
• Phase: N/A
• First received: May 26, 2010
• Last updated: August 18, 2014
• Start date: August 2010
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Cirrhosis
• Hepatic Encephalopathy
• Liver Cirrhosis
• Minimal Hepatic Encephalopathy

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reverse minimal hepatic encephalopathy	Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy	3 months	No
Primary	Reverse minimal hepatic encephalopathy	Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy	6 months	No
Secondary	Prevention of progression	Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.	3 months	No
Secondary	Prevention of progression	Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy	6 months	No