Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

Conditions: Hepatic Cirrhosis; Minimal Hepatic Encephalopathy

Treatments: Dietary Supplement: Hyperproteic and fiber-rich diet; Other: Auxiliary Treatment; Drug: Nitazoxanide

Study type: Interventional

Funder types: Other

Identifiers

NCT01135628

GAS-83-09/10-1

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

MHE and diet plus lactobacillus reuteri

Active Comparator group

Description:

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

Treatment:

Other: Auxiliary Treatment

Dietary Supplement: Hyperproteic and fiber-rich diet

MHE and diet

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Hyperproteic and fiber-rich diet

MHE and diet plus nitazoxanide

Active Comparator group

Description:

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

Treatment:

Drug: Nitazoxanide

Dietary Supplement: Hyperproteic and fiber-rich diet