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Completed

NCT Number: NCT01904513

Investigating the Effects of Probiotic Yogurt on Reducing the Levels of Environmental Toxins Among School Children in Mwanza, Tanzania

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.

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Key information

Conditions

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Medical Research

Mwanza, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 6-10
  • Attends Lake Primary School (Mwanza, Tanzania)

Exclusion criteria

  • Allergic to milk/ milk products
  • Lactose intolerant

Treatment and study plan

Pasteurized Whole Milk

Dietary Supplement

Lactobacillus rhamnosus GR-1

Dietary Supplement

Other names: L. rhamnosus ATCC 55826

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in Microbiota Composition

    Time frame: Before and after the 25 day intervention period.

    Stool microbiota composition shifts as determined by 16S rRNA profiling.

  2. Microbes linked to host toxin levels

    Time frame: Initial sample collection visit

    Microbes, as determined via 16S rRNA sequencing, associated with high toxin levels.

  3. 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

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • National Institute for Medical Research, Tanzania

Registry information

Acronym: PDTX

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 22, 2013
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.