NCT00312078

Brief Summary

The purpose of this study is to determine whether a special yogurt can improve performance on certain tests of intelligence and decrease liver inflammation in patients with cirrhosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

April 5, 2006

Last Update Submit

October 31, 2007

Conditions

CirrhosisMinimal Hepatic Encephalopathy

Keywords

Minimal Hepatic EncephalopathyCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Reversal of minimal hepatic encephalopathy

Secondary Outcomes (1)

  • Decrease in AST/ALT

Interventions

Yogurt SupplementationDIETARY_SUPPLEMENT

Eligibility Criteria

Age24 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis diagnosed on clinical grounds (within 3 months of enrollment)
  • MHE diagnosed by abnormalities in a psychometric battery (NCT-A,BDT,DST and ICT)

You may not qualify if:

  • Current or recent (\< 6 month) use of alcohol
  • Co-existing cause of liver dysfunction
  • Use of antibiotics within last 6 weeks
  • Infection or gastrointestinal hemorrhage within the last 6 weeks
  • Hepatocellular carcinoma
  • Psychoactive drug use, including interferon concurrently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GCRC Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jasmohan S Bajaj, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 7, 2006

Study Start

November 1, 2005

Study Completion

April 1, 2007

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

US(1)