Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Study Overview
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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.

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

Conditions
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Hepatic Cirrhosis, Minimal Hepatic Encephalopathy

Intervention / Treatment
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* Other: Auxiliary Treatment
* Dietary Supplement: Hyperproteic and fiber-rich diet
* Drug: Nitazoxanide


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MHE and diet plus lactobacillus reuteri<br>Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri. | Other: Auxiliary Treatment<br>* Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months<br>* Other names: Probiotics;Dietary Supplement: Hyperproteic and fiber-rich diet<br>* Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet<br>|
| Active Comparator: MHE and diet<br>Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods. | Dietary Supplement: Hyperproteic and fiber-rich diet<br>* Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet<br>|
| Active Comparator: MHE and diet plus nitazoxanide<br>Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide. | Dietary Supplement: Hyperproteic and fiber-rich diet<br>* Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet<br>Drug: Nitazoxanide<br>* Nitazoxanide tablets 400 mg, bid, orally for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of progression | Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy. | 3 months | 
| Prevention of progression | Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic cirrhosis, Minimal hepatic encephalopathy, Hyperproteic and fiber-rich diet, Lactobacillus reuteri, Psychometric Hepatic Encephalopathy Score (PHES), Critical Flicker Frequency (CFF)