Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
This study is currently recruiting participants.
Verified August 2011 by Region Skane
Sponsor:
Region Skane
Collaborator:
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01423630
First received: August 23, 2011
Last updated: August 25, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fatty Liver |
Dietary Supplement: Probiotics and fruit fibre |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver |
Resource links provided by NLM:
Further study details as provided by Region Skane:
Primary Outcome Measures:
- Improved and normalized liver status [ Time Frame: after 12 weeks intervention ] [ Designated as safety issue: No ]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 [ Time Frame: after 12 weeks intervention ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Probiotics and fruit fibre
Probiotics and fruit fibre
|
Dietary Supplement: Probiotics and fruit fibre
probiotics and fruit fibre
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- be able to participate in magnetic resonance imaging
Exclusion Criteria:
- unable to understand oral and written information
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423630
Contacts
| Contact: Bengt Jeppsson, MD, PhD | bengt.jeppsson@med.lu.se | |
| Contact: Ingrid Palmquist | Ingrid.Palmquist@med.lu.se |
Locations
| Sweden | |
| Skåne University Hospital | Recruiting |
| Malmö, Sweden | |
| Contact: Ingrid Palmquist Ingrid.Palmquist@med.lu.se | |
| Contact: Bengt Jeppsson, MD, PhD bengt.jeppsson@med.lu.se | |
Sponsors and Collaborators
Region Skane
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
More Information
No publications provided
| Responsible Party: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT01423630 History of Changes |
| Other Study ID Numbers: | 2008/517 |
| Study First Received: | August 23, 2011 |
| Last Updated: | August 25, 2011 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
Keywords provided by Region Skane:
|
fatty liver probiotics Lactobacillus fruit |
fibre dietary intervention obesity |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013