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NCT Number: NCT01135628

Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

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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Key information

Conditions

Hepatic Cirrhosis Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Minimal Hepatic Encephalopathy Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14000, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auxiliary Treatment

Other

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

Other names: Biogaia, Probiotics

Hyperproteic and fiber-rich diet

Dietary Supplement

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

Nitazoxanide

Drug

Nitazoxanide tablets 400 mg, bid, orally for 6 months

Primary outcomes

  1. Reverse minimal hepatic encephalopathy

    Time frame: 3 months

    Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy

  2. Reverse minimal hepatic encephalopathy

    Time frame: 6 months

    Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy

Secondary outcomes

  1. Prevention of progression

    Time frame: 3 months

    Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.

  2. Prevention of progression

    Time frame: 6 months

    Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2010
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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