Back to resultsSupplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
Primary Purpose
Fatty Liver
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotics and fruit fibre
Sponsored by
About this trial
This is an interventional treatment trial for Fatty Liver focused on measuring fatty liver, probiotics, Lactobacillus, fruit, fibre, dietary intervention, obesity
Eligibility Criteria
Inclusion Criteria:
- be able to participate in magnetic resonance imaging
Exclusion Criteria:
- unable to understand oral and written information
Sites / Locations
- Skåne University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Probiotics and fruit fibre
Arm Description
Probiotics and fruit fibre
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01423630
First Posted
August 23, 2011
Last Updated
January 8, 2022
Sponsor
Region Skane
Collaborators
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
1. Study Identification
Unique Protocol Identification Number
NCT01423630
Brief Title
Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
Official Title
Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of eligible patients and study staff
Study Start Date
August 2011 (Actual)
Primary Completion Date
January 4, 2022 (Actual)
Study Completion Date
January 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. The improved ecological system is believed to contribute to improved liver health and thereby counteract fatty liver disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
Keywords
fatty liver, probiotics, Lactobacillus, fruit, fibre, dietary intervention, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics and fruit fibre
Arm Type
Experimental
Arm Description
Probiotics and fruit fibre
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics and fruit fibre
Intervention Description
probiotics and fruit fibre
Primary Outcome Measure Information:
Title
Improved and normalized liver status
Description
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.
Time Frame
after 12 weeks intervention
Secondary Outcome Measure Information:
Title
Changes in the gut bacterial flora
Description
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.
Time Frame
after 12 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be able to participate in magnetic resonance imaging
Exclusion Criteria:
unable to understand oral and written information
Facility Information:
Facility Name
Skåne University Hospital
City
Malmö
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
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