Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Cirrhosis Minimal Hepatic Encephalopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MHE and diet plus lactobacillus reuteri

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

Group Type ACTIVE_COMPARATOR

Auxiliary Treatment

Intervention Type OTHER

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

Hyperproteic and fiber-rich diet

Intervention Type DIETARY_SUPPLEMENT

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

MHE and diet

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

Group Type ACTIVE_COMPARATOR

Hyperproteic and fiber-rich diet

Intervention Type DIETARY_SUPPLEMENT

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

MHE and diet plus nitazoxanide

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

Group Type ACTIVE_COMPARATOR

Hyperproteic and fiber-rich diet

Intervention Type DIETARY_SUPPLEMENT

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

Nitazoxanide

Intervention Type DRUG

Nitazoxanide tablets 400 mg, bid, orally for 6 months

Interventions

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Auxiliary Treatment

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

Intervention Type OTHER

Hyperproteic and fiber-rich diet

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

Intervention Type DIETARY_SUPPLEMENT

Nitazoxanide

Nitazoxanide tablets 400 mg, bid, orally for 6 months

Intervention Type DRUG

Other Intervention Names

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Biogaia Probiotics

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No