NCT01423630

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2022

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

10.4 years

First QC Date

August 23, 2011

Last Update Submit

January 8, 2022

Conditions

Fatty Liver

Keywords

fatty liverprobioticsLactobacillusfruitfibredietary interventionobesity

Outcome Measures

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.

    after 12 weeks intervention

Secondary Outcomes (1)

  • Changes in the gut bacterial flora

    after 12 weeks intervention

Study Arms (1)

Probiotics and fruit fibre

EXPERIMENTAL

Probiotics and fruit fibre

Dietary Supplement: Probiotics and fruit fibre

Interventions

Probiotics and fruit fibreDIETARY_SUPPLEMENT

probiotics and fruit fibre

Probiotics and fruit fibre

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be able to participate in magnetic resonance imaging

You may not qualify if:

  • unable to understand oral and written information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, Sweden

Location

MeSH Terms

Conditions

Fatty LiverObesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 26, 2011

Study Start

August 1, 2011

Primary Completion

January 4, 2022

Study Completion

January 4, 2022

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

SE(1)