Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Region Skane
Sponsor:
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 5, 2013
Last verified: August 2013
  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 2018
Estimated Primary Completion Date: August 2014 (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
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, see Learn About Clinical Studies.

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 5, 2013
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 September 29, 2014