C535854PDTXNCT01904513
Investigating the Effects of Probiotic Yogurt on Reducing the Levels of Environmental Toxins Among School Children in Mwanza, Tanzania
A study testing Pasteurized Whole Milk and Lactobacillus rhamnosus GR-1 in people with C535854 and D004786, run by Western University, Canada at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- What is being tested?
- Pasteurized Whole Milk and Lactobacillus rhamnosus GR-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTanzania
- Study dates
- Dec 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 6-10
- Attends Lake Primary School (Mwanza, Tanzania)
Who cannot join
- Allergic to milk/ milk products
- Lactose intolerant
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Pasteurized Whole Milk, Lactobacillus rhamnosus GR-1
- Keywords
- Metals, Pesticides, Toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized Whole MilkDietary supplement
Lactobacillus rhamnosus GR-1Dietary supplement
Also called L. rhamnosus ATCC 55826
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Daily consumption of yogurt supplemented with L. rhamnosus GR-1 at ~10^10 CFU/day Receives: Dietary Supplement: Lactobacillus rhamnosus GR-1 |
| Milk | Other | Daily consumption of pasteurized whole milk Receives: Dietary Supplement: Pasteurized Whole Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Toxin Levels
Body toxin levels (metals, pesticides) by HR-SF-ICP-MS and GC/MS.
Measured: Before and after the 25 day intervention period.
Secondary outcomes (3)
Changes in Microbiota Composition
Stool microbiota composition shifts as determined by 16S rRNA profiling.
Measured: Before and after the 25 day intervention period.
Microbes linked to host toxin levels
Microbes, as determined via 16S rRNA sequencing, associated with high toxin levels.
Measured: Initial sample collection visit
Changes in host metabolism due to probiotic instillation
Host metabolic shifts as measured by NMR from urine
Measured: Before and after the 25 day intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for C535854Studies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania
- Responsible party
- Principal investigator, Dr. Gregor Reid, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904513
- Sponsor's protocol ID
- 102881
- Acronym
- PDTX
- Status last verified
- Dec 2013
- First submitted
- 4 Jul 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25293764
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Probiotic Yogurt on Reducing the Levels of Environmental Toxins Among School Children in Mwanza, Tanzania
- ClinicalTrials.gov ID
- NCT01904513
- Acronym / sponsor ID
- PDTX / 102881
- Keywords
- Metals, Pesticides, Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Lactobacillus rhamnosus GR-1Daily consumption of yogurt supplemented with L. rhamnosus GR-1 at ~10^10 CFU/day |
| Milk | Other | Dietary Supplement: Pasteurized Whole MilkDaily consumption of pasteurized whole milk |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 6-10
- Attends Lake Primary School (Mwanza, Tanzania)
Key exclusion criteria (2 listed)
- Allergic to milk/ milk products
- Lactose intolerant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasteurized Whole Milk | Dietary supplement | Milk |
| Lactobacillus rhamnosus GR-1Also: L. rhamnosus ATCC 55826 | Dietary supplement | Probiotic |
Primary outcome
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.
3 secondary outcomes
Changes in Microbiota Composition
Time frame: Before and after the 25 day intervention period.
Microbes linked to host toxin levels
Time frame: Initial sample collection visit
Changes in host metabolism due to probiotic instillation
Time frame: Before and after the 25 day intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Derived from this study: PubMed 25293764Bisanz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurized Whole Milk and Lactobacillus rhamnosus GR-1 in people with C535854 and D004786, run by Western University, Canada at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Body Toxin Levels (time frame: Before and after the 25 day intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.