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

Study Overview
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Brief Summary
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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.

Official Title
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Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being

Conditions
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Obesity, Metabolic Syndrome, Inflammation

Intervention / Treatment
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* Dietary Supplement: Ls-33


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12-15 years IsoBMI>30 Exclusion Criteria: Chronical diseases Chronical medication

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Ls-33|10 10 CFU/day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota diversity |  | one year | 
| Inflammation, CRP | high sensitive C-reactive protein | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antropometry |  | one year | 
| Blood pressure |  | one year | 
| Blood lipids |  | one year | 
| Fasting insulin |  | one year | 
| Fasting glucose |  | one year | 
| C-reactive protein (CRP) |  | 6 months | 
| Fecal calprotectin |  | 7 months | 
| Interleukin-6 (Il-6) |  | one year | 
| Interleukin-10 (IL-10) |  | one year | 
| Tumor necrosis factor-alpha(TNF-α) |  | one year | 
| Adiponectin |  | one year | 
| Leptin |  | one year | 
| GIP |  | one year |