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Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Primary Purpose

Hepatic Cirrhosis, Minimal Hepatic Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Auxiliary Treatment
Hyperproteic and fiber-rich diet
Nitazoxanide
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Cirrhosis focused on measuring Hepatic cirrhosis, Minimal hepatic encephalopathy, Hyperproteic and fiber-rich diet, Lactobacillus reuteri, Psychometric Hepatic Encephalopathy Score (PHES), Critical Flicker Frequency (CFF)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

MHE and diet plus lactobacillus reuteri

MHE and diet

MHE and diet plus nitazoxanide

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Reverse minimal hepatic encephalopathy
Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy
Reverse minimal hepatic encephalopathy
Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2010
Last Updated
August 18, 2014
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT01135628
Brief Title
Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy
Official Title
Hyperproteic and Fiber-rich Diet Plus Probiotics (Lactobacillus Reuteri) and Nitazoxanide in the Treatment of Minimal Hepatic Encephalopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Cirrhosis, Minimal Hepatic Encephalopathy
Keywords
Hepatic cirrhosis, Minimal hepatic encephalopathy, Hyperproteic and fiber-rich diet, Lactobacillus reuteri, Psychometric Hepatic Encephalopathy Score (PHES), Critical Flicker Frequency (CFF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MHE and diet plus lactobacillus reuteri
Arm Type
Active Comparator
Arm Description
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and lactobacillus reuteri.
Arm Title
MHE and diet
Arm Type
Active Comparator
Arm Description
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods.
Arm Title
MHE and diet plus nitazoxanide
Arm Type
Active Comparator
Arm Description
Patients with minimal hepatic encephalopathy managed with diet consisting in hyperproteic and fiber-rich foods and nitazoxanide.
Intervention Type
Other
Intervention Name(s)
Auxiliary Treatment
Other Intervention Name(s)
Biogaia, Probiotics
Intervention Description
Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Hyperproteic and fiber-rich diet
Intervention Description
Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Intervention Description
Nitazoxanide tablets 400 mg, bid, orally for 6 months
Primary Outcome Measure Information:
Title
Reverse minimal hepatic encephalopathy
Description
Reverse minimal hepatic encephalopathy to none evidence of hepatic encephalopathy
Time Frame
3 months
Title
Reverse minimal hepatic encephalopathy
Description
Reverse minimal hepatic encephalopathy to none evidence of clinical hepatic encephalopathy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Prevention of progression
Description
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy.
Time Frame
3 months
Title
Prevention of progression
Description
Prevention of progression from minimal hepatic encephalopathy to any clinical stage of West Haven score of hepatic encephalopathy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Torre-Delgadillo, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas de Nutricion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

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Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

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