PROBESITY-2: Synbiotics in Pediatric Obesity
Condition: Obesity, Childhood; Obesity, Adolescent
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The global obesity epidemic presents an unprecedented challenge to the public health
      worldwide. The factors associated with obesity are complex, and include health behaviours,
      such as eating habits and daily physical activity, and broader social, environmental and
      biological determinants that influence these health behaviours. The intestinal microbiota has
      several beneficial functions related to host health and accumulating evidence indicates that
      the gut microbiota plays a significant role in the development of obesity, obesity-associated
      inflammation and insulin resistance. Differences in community composition, functional genes
      and metabolic activities of the gut microbiota appear to distinguish lean vs obese
      individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or
      its complications. Recent studies have suggested some beneficial effects of probiotics and/or
      prebiotics on obesity and metabolic syndrome in adults; such experience is limited in
      children and adolescents. There are limited information about the synbiotics in children and
      adolescent with obesity.The mechanism of action of probotics on obesity are scarce and
      microbiota restoration/reshaping might be the one. The objective of this study tested the
      effects of a multispecies synbiotic on anthropometric measurement, glucose metabolism, lipid
      parameters and intestinal microbiota in children with exogenous obesity.
    

Detailed description: 
      The global obesity epidemic presents an unprecedented challenge to the public health
      worldwide. The factors associated with obesity are complex, and include health behaviours,
      such as eating habits and daily physical activity, and broader social, environmental and
      biological determinants that influence these health behaviours. The intestinal microbiota has
      several beneficial functions related to host health and accumulating evidence indicates that
      the gut microbiota plays a significant role in the development of obesity, obesity-associated
      inflammation and insulin resistance. Differences in community composition, functional genes
      and metabolic activities of the gut microbiota appear to distinguish lean vs obese
      individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or
      its complications. Recent studies have suggested some beneficial effects of probiotics and/or
      prebiotics on obesity and metabolic syndrome in adults; such experience is limited in
      children and adolescents. There are limited information about the synbiotics in children and
      adolescent with obesity.The mechanism of action of probotics on obesity are scarce and
      microbiota restoration/reshaping might be the one. The objective of this study tested the
      effects of a multispecies synbiotic on anthropometric measurement, glucose metabolism, lipid
      parameters and intestinal microbiota in children with exogenous obesity.

      This is a randomized, double-blind, placebo-controlled clinical study with 61 children, aged
      between 8 to 17 years-old, with exogenous obesity which received a daily dose of a
      multispecies symbiotic formulation or a placebo for 12 weeks. At entry, the anthropometric
      measures included weight, height, waist and hip circumference were recorded. Waist
      circumference to height ratio, waist circumference to hip circumference ratio and body mass
      index (BMI) was calculated. Venous blood samples were drawn after a minimum 8 hours fasting
      for measures including serum glucose, insulin, total cholesterol, low-density lipoprotein
      (LDL), high-density lipoprotein (HDL), triglycerides, C-reactive protein (CRP), erythrocyte
      sedimentation rate; at admission and 12 weeks later. Both groups were treated with a standard
      diet and increased physical activity. Patients were randomly allocated into two groups in a
      ratio of 1:1. Randomization with permutated blocks was done using the online software tool.
      First group received a daily synbiotic supplementation which consisted of a daily probiotic
      mixture including Lactobacillus acidophilus), Lactobacillus rhamnosus, Bifidobacterium
      bifidum, Bifidobacterium longum, Enterococcus faecium (total 2.5 x109CFU/sachet),
      fructooligosaccharydes (FOS) 625 mg, lactulose 400 mg, vitamin A (6 mg), B1 (1.8 mg), B2 (1.6
      mg), B6 (2.4 mg), E (30 mg), C (75 mg) for 12 weeks. Second group received placebo for 12
      weeks. Each visit (Day 0 and 12 weeks later), stool samples were also collected. The V3 and
      V4 regions of the 16S rRNA gene were amplified following the 16S Metagenomic Sequencing
      Library Preparation. The primary end point of this study was to evaluate the effect of the
      multispecies synbiotic would on weight loss (reduction as percentage for weight and body mass
      index). Secondary endpoints were the evolution of the other anthropometeic measurements,
      glucose and lipid metabolism and intestinal microbiota composition.
    

Intervention name(s): Synbiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Oral sachet, for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind, placebo controlled clinical study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Obesity; Synbiotic; Microbiota; Microbiome