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TerminatedNCT01423630Updated Jan 25, 2022

Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver

An interventional study of Probiotics and fruit fibre in Fatty Liver, sponsored by Region Skane. Terminated at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

Why this study was terminated
Lack of eligible patients and study staff
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fatty Liver

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Keywords

  • fatty liver
  • probiotics
  • Lactobacillus
  • fruit
  • fibre
  • dietary intervention
  • obesity
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 11 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • be able to participate in magnetic resonance imaging

Exclusion criteria

Exclusion Criteria:

  • unable to understand oral and written information
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Probiotics and fruit fibre

    Probiotics and fruit fibre

    Dietary Supplement: Probiotics and fruit fibre

Interventions

  • Dietary supplementProbiotics and fruit fibre

    probiotics and fruit fibre

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: after 12 weeks intervention

Secondary outcomes

  1. 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.

    Time frame: after 12 weeks intervention

07

Study locations

1 site
  • Skåne University Hospital
    Malmö, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01423630
Lead sponsor
Region Skane
Collaborators
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Responsible party
Sponsor
First posted
Aug 26, 2011
Start date
Aug 2011
Primary completion
Jan 4, 2022
Completion
Jan 4, 2022
Last update
Jan 25, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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