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Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

NCT01135628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-08-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Aldo Torre-Delgadillo, MD · Instituto Nacional de Ciencias Medicas de Nutricion

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135628 on ClinicalTrials.gov