NCT00992290

Brief Summary

This research proposes to find whether the probiotic lactobacillus GG is safe and well tolerated in patients with minimal hepatic encephalopathy. We also want to get insight into the mechanisms of action of LGG.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

October 6, 2009

Last Update Submit

January 6, 2014

Conditions

Minimal Hepatic Encephalopathy

Keywords

cirrhosishepatic encephalopathycomplicationsprobioticlactobacillus GG

Outcome Measures

Primary Outcomes (1)

  • Safety of LGG

    3 years

Secondary Outcomes (3)

  • Quality of life measured by sickness impact profile

    3 years

  • Bacteriology measured in the stool flora by specialized non-culture techniques

    3 years

  • Metabonomics and psychometric testing using a standard psychometric battery

    3 years

Study Arms (2)

Lactobacillus GG

EXPERIMENTAL
Biological: Lactobacillus GG

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

Lactobacillus GGBIOLOGICAL

1 capsule of lactobacillus GG BID compared to placebo BID

Lactobacillus GG
PlaceboBIOLOGICAL

1 capsule of lactobacillus GG BID compared to placebo BID

Placebo

Eligibility Criteria

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

You may qualify if:

  • Age: 18-65 years
  • Histological evidence of cirrhosis
  • Maintenance of cirrhosis treatment and stability for 6 months
  • Mini-mental state exam score \> 25
  • Presence of MHE on psychometric testing

You may not qualify if:

  • Rx for MHE or OHE
  • Antibiotics within 6 weeks
  • Yogurt consumption within 2 weeks
  • Neutrophil count \< 500
  • Inflammatory bowel disease
  • History of pancreatitis
  • Hepato-cellular carcinoma
  • Recent (6 weeks) gastrointestinal bleed
  • Recent (6 months) alcohol intake
  • Psychoactive medications (including interferon/antipsychotics)
  • Liver transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

FibrosisHepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jasmohan S Bajaj, MD, MSc

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 9, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(1)