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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01135628

Enrollment

Registered

2010-06-03

Start date

2010-08-31

Completion date

2014-07-31

Last updated

2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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.

Interventions

OTHERAuxiliary Treatment

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

DIETARY_SUPPLEMENTHyperproteic and fiber-rich diet

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

DRUGNitazoxanide

Nitazoxanide tablets 400 mg, bid, orally for 6 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Reverse minimal hepatic encephalopathy	3 months	Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026