Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
This study is currently recruiting participants.
Verified August 2011 by Region Skane
Sponsor:
Region Skane
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 25, 2011
Last verified: August 2011
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 23, 2011 | ||||||||
| Last Updated Date | August 25, 2011 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01423630 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver | ||||||||
| Official Title ICMJE | Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Fatty Liver | ||||||||
| Intervention ICMJE | Dietary Supplement: Probiotics and fruit fibre
probiotics and fruit fibre |
||||||||
| Study Arm (s) | Experimental: Probiotics and fruit fibre
Probiotics and fruit fibre
Intervention: Dietary Supplement: Probiotics and fruit fibre |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | August 2016 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01423630 | ||||||||
| Other Study ID Numbers ICMJE | 2008/517 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Region Skane | ||||||||
| Study Sponsor ICMJE | Region Skane | ||||||||
| Collaborators ICMJE | The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS) | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Region Skane | ||||||||
| Verification Date | August 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||