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

NCT ID: NCT01904513

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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C535854 D004786

Keywords

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Metals Pesticides Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Probiotic

Daily consumption of yogurt supplemented with L. rhamnosus GR-1 at \~10\^10 CFU/day

Group Type EXPERIMENTAL

Lactobacillus rhamnosus GR-1

Intervention Type DIETARY_SUPPLEMENT

Milk

Daily consumption of pasteurized whole milk

Group Type OTHER

Pasteurized Whole Milk

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Pasteurized Whole Milk

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus rhamnosus GR-1

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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L. rhamnosus ATCC 55826

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Allergic to milk/ milk products
* Lactose intolerant
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role collaborator

Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gregor Reid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Institute for Medical Research

Mwanza, , Tanzania

Site Status

Countries

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Tanzania

References

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Bisanz JE, Enos MK, Mwanga JR, Changalucha J, Burton JP, Gloor GB, Reid G. Randomized open-label pilot study of the influence of probiotics and the gut microbiome on toxic metal levels in Tanzanian pregnant women and school children. mBio. 2014 Oct 7;5(5):e01580-14. doi: 10.1128/mBio.01580-14.

Reference Type DERIVED
PMID: 25293764 (View on PubMed)

Other Identifiers

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102881

Identifier Type: -

Identifier Source: org_study_id