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NCT01423630 Clinical Trial

Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver

Fatty Liver Clinical Trial

Official title:
Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01423630
Other study ID # 2008/517
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date January 4, 2022

Study information
Verified date January 2022
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The improved ecological system is believed to contribute to improved liver health and thereby counteract fatty liver disease.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date January 4, 2022
Est. primary completion date January 4, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - be able to participate in magnetic resonance imaging Exclusion Criteria: - unable to understand oral and written information

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotics and fruit fibre
probiotics and fruit fibre

Locations
Country Name City State
Sweden Skåne University Hospital Malmö

Sponsors (2)
Lead Sponsor Collaborator
Region Skane The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. after 12 weeks intervention
Secondary 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. after 12 weeks intervention
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