NCT01113567

Brief Summary

Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive "lactose-free" milk (3.5 g of lactose) two times a day for 21 days. Clinical history, nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days. An external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2021

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

11.1 years

First QC Date

April 28, 2010

Last Update Submit

February 7, 2023

Conditions

Hepatic EncephalopathyLiver Cirrhosis

Keywords

Hepatic EncephalopathyLiver CirrhosisDisaccharidesLactoseQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis

    Improve in Psychometric Hepatic Encephalopathy Score (PHES). The PHES includes five psychometric test: number connectiontests A and B; the digit symbol test; the line tracing test and the serial dotting test. To calculate th PHES, the validated equations for Mexican population will be used. Patients will be diagnosed with MHE when the PHES will be less than -4 points.

    30 days after intervention

Secondary Outcomes (1)

  • Quality of life in patients with cirrhosis and minimal hepatic encephalopathy

    30 days after intervention

Study Arms (2)

Diet and lactose-free milk

PLACEBO COMPARATOR

Lactose-free milk

Dietary Supplement: Lactose-free milk

Diet and whole milk

ACTIVE COMPARATOR

Whole milk with lactose

Dietary Supplement: Whole milk

Interventions

Lactose-free milkDIETARY_SUPPLEMENT

3.5 g of lactose

Diet and lactose-free milk
Whole milkDIETARY_SUPPLEMENT

Whole milk with 24 g lactose

Diet and whole milk

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic liver disease of whichever etiology
  • Minimal hepatic encephalopathy
  • Lactose maldigestion

You may not qualify if:

  • Patients with clinical manifestations of hepatic encephalopathy
  • Recent use of antibiotics or psychotropic drugs
  • Recent use of alcohol abuse
  • Gastrointestinal bleeding
  • Others neurological disorders that affect the psychometric test
  • Chronic renal failure
  • Congestive heart failure
  • Chronic Obstructive Pulmonary Disease
  • Severe symptoms of lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06725, Mexico

Location

Related Links

MeSH Terms

Conditions

Hepatic EncephalopathyLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Segundo Moran, MD

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asociado B

Study Record Dates

First Submitted

April 28, 2010

First Posted

April 30, 2010

Study Start

July 1, 2010

Primary Completion

July 26, 2021

Study Completion

July 26, 2021

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

ME(1)