Trial record 2 of 302 for:    Encephalopathy

Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01135628
First received: May 26, 2010
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hepatic Cirrhosis
Minimal Hepatic Encephalopathy
Other: Auxiliary Treatment
Dietary Supplement: Hyperproteic and fiber-rich diet
Drug: Nitazoxanide

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperproteic and Fiber-rich Diet Plus Probiotics (Lactobacillus Reuteri) and Nitazoxanide in the Treatment of Minimal Hepatic Encephalopathy.

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Reverse minimal hepatic encephalopathy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy

  • Reverse minimal hepatic encephalopathy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy


Secondary Outcome Measures:
  • Prevention of progression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.

  • Prevention of progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy


Enrollment: 60
Study Start Date: August 2010
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MHE and diet plus lactobacillus reuteri
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.
Other: Auxiliary Treatment
Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months
Other Names:
  • Biogaia
  • Probiotics
Dietary Supplement: Hyperproteic and fiber-rich diet
Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
Active Comparator: MHE and diet
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.
Dietary Supplement: Hyperproteic and fiber-rich diet
Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
Active Comparator: MHE and diet plus nitazoxanide
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.
Dietary Supplement: Hyperproteic and fiber-rich diet
Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
Drug: Nitazoxanide
Nitazoxanide tablets 400 mg, bid, orally for 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135628

Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Aldo Torre-Delgadillo, MD Instituto Nacional de Ciencias Medicas de Nutricion
  More Information

No publications provided

Responsible Party: ALDO TORRE DELGADILLO, M.D. M.Sc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01135628     History of Changes
Other Study ID Numbers: GAS-83-09/10-1
Study First Received: May 26, 2010
Last Updated: August 18, 2014
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Hepatic cirrhosis
Minimal hepatic encephalopathy
Hyperproteic and fiber-rich diet
Lactobacillus reuteri
Psychometric Hepatic Encephalopathy Score (PHES)
Critical Flicker Frequency (CFF)

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Diseases
Liver Cirrhosis
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014