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Completed

NCT Number: NCT02022137

Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy

As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans have shown prebiotic effects, and have shown to improve function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving health and quality of life of patients with MHE.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

México, D.f., 1400, Mexico

About this study

Hepatic encephalopathy (HE) is a potentially reversible neuropsychiatric syndrome characterized by changes in cognitive function, behavior and personality of patients with chronic liver disease or cirrhosis. Increased concentration of ammonia is the main precipitant of encephalopathy and brain astrocytes are the main affected cells in the neuropathology of this disease. The toxicity of ammonia together with the neutrophil dysfunction and oxidative stress and inflammation secondary to infection, result in a progressive decline in quality of life and an increased risk of accidents for patients with this disease.

About 28% of patients with liver cirrhosis develop encephalopathy during the course of the disease and within this percentage, 84% will develop MHE. Currently, chronic liver diseases are the third leading cause of death in Mexico. The high prevalence suggests that HE could become a public health problem, with the 2020 projected figures of 1.5 million people with cirrhosis, which represents approximately 400 000 to 500 000 people with probable encephalopathy.

The usual treatment of MHE is the use of antibiotics or pro and prebiotics, these enhances the performance and quality of life of patients who have the disease. The general consensus has been using lactulose or lactitol as the first treatment options for MHE consistent with data from previous studies. However, the rate of adherence to treatment with lactulose and lactitol is low, especially in patients with MHE with no symptoms and lack of specific information about their problems, to adhere to medications that can cause diarrhea and flatulence.

In the last eight years functional ingredients have been studied as alternatives to the treatment of patients with MHE. In 2004, Liu et al showed that 25% chicory inulin (prebiotic) and this combined with probiotics improve the psychometric function of MHE patients. In similar studies conducted in 2007 and 2009 in which they used a formulation with a symbiotic fructo-oligosaccharides based chicory inulin and B. longum, showed improvement in psychometric tests applied to patients. In 2008, Bajaj et al showed that patients who consumed a yogurt with probiotics, showed significant changes in the degree of MHE.

As an alternative for treating the MHE we found Agave tequilana Weber fructans, which present prebiotic effect, besides having shown to improve the function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving the health and quality of life of patients with MHE.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 to 70 years.
  • Liver cirrhosis of any etiology.
  • Presence of minimal hepatic encephalopathy.
  • Presence of hepatic encephalopathy I

Exclusion criteria

  • Hepatic encephalopathy II or III
  • Use of antibiotics in the previous month.
  • Presence of immunological diseases.
  • Consumption of probiotics.
  • Patients with hepato-renal diseases.
  • Patients who do not agree to participate in the project.

Treatment and study plan

Red cereal bar

Dietary Supplement

Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.

Green cereal bar

Dietary Supplement

Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.

White cereal bar

Dietary Supplement

Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.

Primary outcomes

  1. Minimal hepatic encephalopathy

    Time frame: 2 months

    Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)

Secondary outcomes

  1. Nutritional Status

    Time frame: 2 months

    Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculate mid-arm muscle circumference, and bioelectrical impedance vector analysis.

Other outcomes

  1. Ammonia, liver function tests

    Time frame: baseline and 2 months

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

Evaluation of the Effect of a Cereal Bar With Added Agave Fructans or Lactitol or Lactose, in Patients With Minimal Hepatic Encephalopathy

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 27, 2013
Registry last updated
Jun 8, 2016

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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