Investigating the Effects of Probiotic Yogurt on Reducing the Levels of Environmental Toxins Among School Children in Mwanza, Tanzania (PDTX)
|ClinicalTrials.gov Identifier: NCT01904513|
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : December 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|C535854 D004786||Dietary Supplement: Pasteurized Whole Milk Dietary Supplement: Lactobacillus rhamnosus GR-1||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating the Effects of Probiotic Yogurt on Reducing the Levels of Environmental Toxins Among School Children in Mwanza, Tanzania|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||August 2013|
Daily consumption of yogurt supplemented with L. rhamnosus GR-1 at ~10^10 CFU/day
Dietary Supplement: Lactobacillus rhamnosus GR-1
Other Name: L. rhamnosus ATCC 55826
Daily consumption of pasteurized whole milk
Dietary Supplement: Pasteurized Whole Milk
- Changes in Body Toxin Levels [ Time Frame: Before and after the 25 day intervention period. ]Body toxin levels (metals, pesticides) by HR-SF-ICP-MS and GC/MS.
- Changes in Microbiota Composition [ Time Frame: Before and after the 25 day intervention period. ]Stool microbiota composition shifts as determined by 16S rRNA profiling.
- Microbes linked to host toxin levels [ Time Frame: Initial sample collection visit ]Microbes, as determined via 16S rRNA sequencing, associated with high toxin levels.
- Changes in host metabolism due to probiotic instillation [ Time Frame: Before and after the 25 day intervention period. ]Host metabolic shifts as measured by NMR from urine
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904513
|National Institute for Medical Research|