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The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children

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. Identifier: NCT01020617
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : January 19, 2011
The Danish Medical Research Council
Information provided by:
University of Copenhagen

Brief Summary:

Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004).

Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Inflammation Obesity Dietary Supplement: Ls-33 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being
Study Start Date : April 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Dietary Supplement: Ls-33
    10~10 CFU/day
    Other Name: L. salivarius Ls-33

Primary Outcome Measures :
  1. Microbiota diversity [ Time Frame: one year ]
  2. Inflammation, CRP [ Time Frame: 2 months ]
    high sensitive C-reactive protein

Secondary Outcome Measures :
  1. Antropometry [ Time Frame: one year ]
  2. Blood pressure [ Time Frame: one year ]
  3. Blood lipids [ Time Frame: one year ]
  4. Fasting insulin [ Time Frame: one year ]
  5. Fasting glucose [ Time Frame: one year ]
  6. C-reactive protein (CRP) [ Time Frame: 6 months ]
  7. Fecal calprotectin [ Time Frame: 7 months ]
  8. Interleukin-6 (Il-6) [ Time Frame: one year ]
  9. Interleukin-10 (IL-10) [ Time Frame: one year ]
  10. Tumor necrosis factor-alpha(TNF-α) [ Time Frame: one year ]
  11. Adiponectin [ Time Frame: one year ]
  12. Leptin [ Time Frame: one year ]
  13. GIP [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 12-15 years
  • IsoBMI>30

Exclusion Criteria:

  • Chronical diseases
  • Chronical medication

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 identifier (NCT number): NCT01020617

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Copenhagen University
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Danish Medical Research Council
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Principal Investigator: Kim F Michaelsen, Professor University of Copenhagen, Department of Human Nutrition
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Kim Fleischer Michaelsen, University of Copenhagen, Department of Human Nutrition Identifier: NCT01020617    
Other Study ID Numbers: D206 ProTeen
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: November 2009
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases