CirrhosisNCT00312078
Effect of Yogurt on Minimal Hepatic Encephalopathy
A study testing Yogurt Supplementation in people with Cirrhosis and Minimal Hepatic Encephalopathy, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 65 years
- Conditions the study is for
- Cirrhosis, Minimal Hepatic Encephalopathy
- What is being tested?
- Yogurt Supplementation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis diagnosed on clinical grounds (within 3 months of enrollment)
- MHE diagnosed by abnormalities in a psychometric battery (NCT-A,BDT,DST and ICT)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
GCRC Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Effect of Yogurt Supplementation on Psychometric Test Performance in Cirrhotic Patients With Minimal Hepatic Encephalopathy. A Prospective Pilot Trial.
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.
Read the detailed description
Introduction: Cirrhosis is one of the leading causes of death in the United States. Minimal hepatic encephalopathy (MHE) is a significant complication of cirrhosis, which is often not treated because of perceived subclinical nature of this condition and the adverse effects and expense of available medications such as lactulose or rifaximin. There is evidence that small intestinal bacterial overgrowth can contribute to the development of MHE and cirrhosis in murine and human studies. Probiotics are live bacteria that can modify the indigenous intestinal bacterial flora and have been recently used in the treatment of hepatic encephalopathy in patients with cirrhosis.
Our aim is to evaluate the effect of probiotic supplementation via yogurt on liver function and inflammatory markers of bacterial translocation and psychometric test performance in cirrhotic patients with MHE in a prospective pilot trial.
Methods: 30 patients with MHE 2:1 i.e. 20 will be randomized into supplementation with yogurt to be taken 6 ounces twice a day for 60 days and 10 patients will be followed up without yogurt supplementation. All patients will undergo liver function tests, basic metabolic panel, INR, venous ammonia, IL-6 and TNF-alpha at baseline, 30 days and at 60 days. All patients will also undergo psychometric testing with number connection test A, digit symbol test, block design and inhibitory control test at baseline and 60 days. Regular questioning about adherence to yogurt. Collection of yogurt tops as proof of yogurt consumption and review of intake diary will be done at 30 and 60 days from patients randomized to yogurt supplementation.
Importance: There has been only one human study on the modification of gut flora as a therapeutic tool for improvement of MHE in cirrhosis, however that study included alcoholic liver disease and comprised of Chinese patients, therefore etiologies of liver diseases studied were different from those predominant in the United States. Since MHE can adversely affect quality of life and overall prognosis, simple, targeted therapies are needed to treat it. We believe that our pilot study will help delineate human gut flora as a definite target for therapy of cirrhosis and MHE and pave the way for future large-scale studies on this subject.
- Conditions
- Cirrhosis, Minimal Hepatic Encephalopathy
- Being tested
- Yogurt Supplementation
- Keywords
- Minimal Hepatic Encephalopathy, Cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt SupplementationDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of minimal hepatic encephalopathy
Secondary outcomes (1)
Decrease in AST/ALT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startNov 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Jasmohan S Bajaj, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312078
- Sponsor's protocol ID
- GCRC protocol 810; HRRC 360-05
- Status last verified
- Oct 2007
- First submitted
- 5 Apr 2006
- Last updated
- 1 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yogurt Supplementation on Psychometric Test Performance in Cirrhotic Patients With Minimal Hepatic Encephalopathy. A Prospective Pilot Trial.
- ClinicalTrials.gov ID
- NCT00312078
- Acronym / sponsor ID
- GCRC protocol 810; HRRC 360-05
- Conditions
- Cirrhosis, Minimal Hepatic Encephalopathy
- Keywords
- Minimal Hepatic Encephalopathy, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Nov 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 7 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Cirrhosis is one of the leading causes of death in the United States. Minimal hepatic encephalopathy (MHE) is a significant complication of cirrhosis, which is often not treated because of perceived subclinical nature of this condition and the adverse effects and expense of available medications such as lactulose or rifaximin. There is evidence that small intestinal bacterial overgrowth can contribute to the development of MHE and cirrhosis in murine and human studies. Probiotics are live bacteria that can modify the indigenous intestinal bacterial flora and have been recently used in the treatment of hepatic encephalopathy in patients with cirrhosis.
Our aim is to evaluate the effect of probiotic supplementation via yogurt on liver function and inflammatory markers of bacterial translocation and psychometric test performance in cirrhotic patients with MHE in a prospective pilot trial.
Methods: 30 patients with MHE 2:1 i.e. 20 will be randomized into supplementation with yogurt to be taken 6 ounces twice a day for 60 days and 10 patients will be followed up without yogurt supplementation. All patients will undergo liver function tests, basic metabolic panel, INR, venous ammonia, IL-6 and TNF-alpha at baseline, 30 days and at 60 days. All patients will also undergo psychometric testing with number connection test A, digit symbol test, block design and inhibitory control test at baseline and 60 days. Regular questioning about adherence to yogurt. Collection of yogurt tops as proof of yogurt consumption and review of intake diary will be done at 30 and 60 days from patients randomized to yogurt supplementation.
Importance: There has been only one human study on the modification of gut flora as a therapeutic tool for improvement of MHE in cirrhosis, however that study included alcoholic liver disease and comprised of Chinese patients, therefore etiologies of liver diseases studied were different from those predominant in the United States. Since MHE can adversely affect quality of life and overall prognosis, simple, targeted therapies are needed to treat it. We believe that our pilot study will help delineate human gut flora as a definite target for therapy of cirrhosis and MHE and pave the way for future large-scale studies on this subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhosis diagnosed on clinical grounds (within 3 months of enrollment)
- MHE diagnosed by abnormalities in a psychometric battery (NCT-A,BDT,DST and ICT)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt Supplementation | Dietary supplement | – |
Primary outcome
Reversal of minimal hepatic encephalopathy
1 secondary outcome
Decrease in AST/ALT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmohan S Bajaj, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt Supplementation in people with Cirrhosis and Minimal Hepatic Encephalopathy, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of minimal hepatic encephalopathy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2007.