Fatty LiverPhase 1NCT00099723
The Effect of a Probiotic on Hepatic Steatosis
A Phase 1 study testing VSL#3 in people with Fatty Liver, run by VSL Pharmaceuticals at 1 site in United States.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- VSL#3
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2005
- Phase
- Phase 1
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult-onset diabetes
- Liver biopsy in the previous 2 months with diagnosis of fatty liver and fibrosis stage F2-F3
Who cannot join
- There are multiple exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.
- Conditions
- Fatty Liver
- Being tested
- VSL#3
- Keywords
- Hepatic steatosis, adult-onset diabetes, Non-alcoholic fatty liver disease
- Medical subject headings
- Fatty Liver, Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI
Liver biopsy
Blood work
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2004 (estimated)
- Study startOct 2004
- Study completionDec 2005 (estimated)
Why it stopped: The hypothesis that probiotics would reduce hepatic steatosis in humans was not supported
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VSL Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steve Solga, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099723
- Sponsor's protocol ID
- SS01305-01
- Other IDs
- R21AT001305-01
- Status last verified
- Dec 2004
- First submitted
- 17 Dec 2004
- Last updated
- 11 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Probiotic on Hepatic Steatosis
- ClinicalTrials.gov ID
- NCT00099723
- Acronym / sponsor ID
- SS01305-01
- Conditions
- Fatty Liver
- Keywords
- Hepatic steatosis, adult-onset diabetes, Non-alcoholic fatty liver disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The hypothesis that probiotics would reduce hepatic steatosis in humans was not supported
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VSL PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Dec 2005 (estimated)
- First posted
- 20 Dec 2004 (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.
Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult-onset diabetes
- Liver biopsy in the previous 2 months with diagnosis of fatty liver and fibrosis stage F2-F3
Key exclusion criteria (1 listed)
- There are multiple exclusion criteria.
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 |
|---|---|---|
| VSL#3 | Drug | – |
Primary outcome
MRI
Liver biopsy
Blood work
Results and safety
The study was stopped early (reason given: The hypothesis that probiotics would reduce hepatic steatosis in humans was not supported). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
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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.
Steve Solga, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VSL#3 in people with Fatty Liver, run by VSL Pharmaceuticals 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 1 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: stopped early, as of the sponsor's last update on 11 Feb 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The hypothesis that probiotics would reduce hepatic steatosis in humans was not supported). Results are not available in the source record.
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?
MRI. The study lists 3 primary outcomes in all. 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 11 Feb 2010.