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Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01423630
First Posted: August 26, 2011
Last Update Posted: October 19, 2017
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.
Collaborator:
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Information provided by (Responsible Party):
Region Skane
  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: Single Group Assignment
Masking: None (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 ]
    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 ]
    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
Actual Study Start Date: August 2011
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


Locations
Sweden
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 Submitted: August 23, 2011
First Posted: August 26, 2011
Last Update Posted: October 19, 2017
Last Verified: August 2017

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