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Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01423630
Recruitment Status : Active, not recruiting
First Posted : August 26, 2011
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Fatty Liver Dietary Supplement: Probiotics and fruit fibre

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
Actual Study Start Date : August 2011
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Probiotics and fruit fibre
Probiotics and fruit fibre
Dietary Supplement: Probiotics and fruit fibre
probiotics and fruit fibre

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Changes in the gut bacterial flora [ Time Frame: after 12 weeks intervention ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • be able to participate in magnetic resonance imaging

Exclusion Criteria:

  • unable to understand oral and written information
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423630

Skåne University Hospital
Malmö, Sweden
Sponsors and Collaborators
Region Skane
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
More Information

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01423630     History of Changes
Other Study ID Numbers: 2008/517
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: August 2017

Keywords provided by Region Skane:
fatty liver
dietary intervention

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases