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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fatty Liver

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