Fatty LiverNCT01423630
Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
A study testing Probiotics and fruit fibre in people with Fatty Liver, run by Region Skane at 1 site in Sweden.
Trial summary
Probiotics and fruit fibre are given for 12 weeks to patients with fatty liver disease. The hypothesis is that probiotic bacteria and fruit fibre affect the gut microbial composition in a positive manner. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Probiotics and fruit fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to 4 Jan 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be able to participate in magnetic resonance imaging
Who cannot join
- unable to understand oral and written information
Trial locations and contacts
1 site in 1 country.
About this study
Probiotics and fruit fibre are given for 12 weeks to patients with fatty liver disease.
The hypothesis is that probiotic bacteria and fruit fibre affect the gut microbial composition in a positive manner. The improved ecological system is believed to contribute to improved liver health and thereby counteract fatty liver disease.
- Conditions
- Fatty Liver
- Being tested
- Probiotics and fruit fibre
- Keywords
- fatty liver, probiotics, Lactobacillus, fruit, fibre, dietary intervention, obesity
- Medical subject headings
- Fatty Liver, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics and fruit fibreDietary supplement
probiotics and fruit fibre
| Study group | Role | What they receive |
|---|---|---|
| Probiotics and fruit fibre | Experimental | Probiotics and fruit fibre Receives: Dietary Supplement: Probiotics and fruit fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved and normalized liver status
normalized concentrations of liver enzymes in plasma. Magnetic resonanse imaging (compared to magnetic resonanse imaging before intervention) will also be used in the investigation of improved liver status.
Measured: after 12 weeks intervention
Secondary outcomes (1)
Changes in the gut bacterial flora
Changes and differences of the gut bacterial flora will be addressed in detail, e.g. changes in concentration of specific bacterial groups (e.g. Lactobacillus) before and after the intervention period.
Measured: after 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Why it stopped: Lack of eligible patients and study staff
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.
- More trials run by Region SkaneThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423630
- Sponsor's protocol ID
- 2008/517
- Status last verified
- Jan 2022
- First submitted
- 23 Aug 2011
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
- ClinicalTrials.gov ID
- NCT01423630
- Acronym / sponsor ID
- 2008/517
- Conditions
- Fatty Liver
- Keywords
- fatty liver, probiotics, Lactobacillus, fruit, fibre, dietary intervention, obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible patients and study staff
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
- Study start
- Aug 2011 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 26 Aug 2011 (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.
Probiotics and fruit fibre are given for 12 weeks to patients with fatty liver disease.
The hypothesis is that probiotic bacteria and fruit fibre affect the gut microbial composition in a positive manner. The improved ecological system is believed to contribute to improved liver health and thereby counteract fatty liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotics and fruit fibre | Experimental | Dietary Supplement: Probiotics and fruit fibreProbiotics and fruit fibre |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- be able to participate in magnetic resonance imaging
Key exclusion criteria (1 listed)
- unable to understand oral and written information
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 |
|---|---|---|
| Probiotics and fruit fibreprobiotics and fruit fibre | Dietary supplement | Probiotics and fruit fibre |
Primary outcome
Improved and normalized liver status
Time frame: after 12 weeks intervention
normalized concentrations of liver enzymes in plasma. Magnetic resonanse imaging (compared to magnetic resonanse imaging before intervention) will also be used in the investigation of improved liver status.
1 secondary outcome
Changes in the gut bacterial flora
Time frame: after 12 weeks intervention
Results and safety
The study was stopped early (reason given: Lack of eligible patients and study staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and fruit fibre in people with Fatty Liver, run by Region Skane at 1 site in Sweden.
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 1 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 25 Jan 2022. 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 Sweden. 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 was stopped early (reason given: Lack of eligible patients and study staff). 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?
Improved and normalized liver status (time frame: after 12 weeks intervention). 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 25 Jan 2022.