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

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ClinicalTrials.gov Identifier: NCT01904513
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : December 17, 2013
Sponsor:
Collaborator:
National Institute for Medical Research, Tanzania
Information provided by (Responsible Party):
Dr. Gregor Reid, Western University, Canada

Brief 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.

Condition or disease Intervention/treatment Phase
C535854 D004786 Dietary Supplement: Pasteurized Whole Milk Dietary Supplement: Lactobacillus rhamnosus GR-1 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Probiotic
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

Milk
Daily consumption of pasteurized whole milk
Dietary Supplement: Pasteurized Whole Milk



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergic to milk/ milk products
  • Lactose intolerant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904513


Locations
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Tanzania
National Institute for Medical Research
Mwanza, Tanzania
Sponsors and Collaborators
Western University, Canada
National Institute for Medical Research, Tanzania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Gregor Reid, Principal Investigator, Western University, Canada
ClinicalTrials.gov Identifier: NCT01904513    
Other Study ID Numbers: 102881
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013
Keywords provided by Dr. Gregor Reid, Western University, Canada:
Metals
Pesticides
Toxicity