Investigating the Effects of Probiotic Yogurt on Reducing the Levels of Environmental Toxins Among School Children in Mwanza, Tanzania
Condition: C535854; D004786
Study type: Interventional

Summary: 
      The primary objective of this pilot study is to determine if consumption of a probiotic
      yogurt causes reduced levels of environmental toxins in a group of school-aged Tanzanian
      children. The secondary objective is to determine the levels of environmental toxins in
      Tanzanian children and compare these to literature values of levels believed to negatively
      affect health and development. The third objective is to analyze the intestinal microbiota of
      the children and to determine if consumption of a probiotic yogurt has a significant affect
      on the microbiota composition.
    

Detailed description: 
      A group of 60 first year students from the Lake Primary School will be recruited for
      inclusion into the study. After gaining consent from the child's caregiver, each child will
      be given a participant number and blood, urine and fecal samples will be collected from each
      child by qualified personnel from NIMR. Children will be randomized into two groups (n=30) to
      match age, sex and weight, one of which will receive a 100 g probiotic yogurt containing
      Lactobacillus rhamnosus GR-1 while the other group will receive an equivalent portion of
      milk. After 30 days of consuming the yogurt or milk, samples will again be collected.

      Samples will be shipped back to London, Ontario Canada on dry ice for analysis. Blood and
      urine will be analyzed via high-resolution sector field inductively coupled plasma mass
      spectrometry (HR-SF-ICP-MS) to determine levels of toxic heavy metals (Mercury, Lead,
      Cadmium, Arsenic). This will be carried out by the London Health Sciences Trace Elements
      laboratory in Canada. Urine will also be analyzed via gas chromatography/ mass spectrometry
      (GC-MS) to determine levels of pesticides at the Biotron Facility (University of Western
      Ontario). We will also examine urine via NMR for potential host metabolic changes in response
      to probiotic instillation.

      Bacterial community DNA samples will be extracted and analyzed to determine the
      gastrointestinal microbiota of the children both before and after administration of the
      probiotic yogurt to determine the effect of the yogurt on the gut microbiome. Briefly, DNA
      will be extracted with the Qiagen Stool DNA extraction kit and bacterial community 16S rRNA
      genes will amplified using barcoded primers specific for a variable region within the gene.
      The samples will be pooled and sequenced on the Ion Torrent platform (London Regional
      Genomics Center, Canada). Reads are then processed and analyzed using custom scripts as well
      as the Quantitative Insights Into Microbial Ecology (QIIME) tool, which is the leading
      package for microbiota analysis.
    

Intervention name(s): Pasteurized Whole Milk; Lactobacillus rhamnosus GR-1
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): L. rhamnosus ATCC 55826
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Metals; Pesticides; Toxicity