Trial | NCT01135628  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
Study Started
Aug 31
2010
Primary Completion
May 31
2014
Study Completion
Jul 31
2014
Last Update
Aug 20
2014
Estimate

Dietary Supplement Hyperproteic and fiber-rich diet

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

Other Auxiliary Treatment

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

  • Other names: Biogaia, Probiotics

Drug Nitazoxanide

Nitazoxanide tablets 400 mg, bid, orally for 6 months

MHE and diet plus lactobacillus reuteri Active Comparator

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

MHE and diet Active Comparator

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

MHE and diet plus nitazoxanide Active Comparator

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

Criteria 

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
No Results Posted