Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya
NCT ID: NCT02041026
Last Updated: 2014-01-20
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2014-02-28
2014-05-31
Brief Summary
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Detailed Description
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Limiting cereal intake is not always easy, as it is one of the most plentiful and nutritious food sources in Kenya and is the primary source of dietary energy for many societies in Kenya.
We have recently discovered a novel property of lactic acid bacteria in which aflatoxin B1, is sequestered and/or detoxified by the microbes causing reduction of toxin levels in their environment. We hypothesize that sequestration of toxins in the gastrointestinal tract by ingested probiotic bacteria will cause a reduction in host toxin uptake by carrying them out of the body in the feces preventing their passage from the gastrointestinal tract into the host. Our primary objective is to test our hypothesis that consumption of a probiotic yogurt will result in decreased levels of Aflatoxin B1 in a group of school-aged children. The secondary objective is to determine the baseline levels of aflatoxin B1 in a group of school-aged children in eastern Kenya. The tertiary objective is to establish the baseline gastrointestinal microbiota of these children and how consumption of a probiotic yogurt affects the microbiota.
A class of 60 pupils from Identified primary school, approximately 7 years old, will be randomized to two groups matching ages, sex and weight. They will receive a daily 100g serving of the probiotic yogurt and a portion of local milk in between the trial period. Before the first administration of the yogurt/milk, blood, urine and feces will be collected. After 30 days; biological specimens will again be collected to observe potential reductions in toxin levels.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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probiotic yoghurt
the subject will be given 200ml of yogurt daily for 28 days
probiotic yoghurt
The probiotic yoghurt will be prepared using lactobacillus NN20 isolated from Kimere (a traditional fermented food product) consumed in eastern part of kenya
Interventions
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probiotic yoghurt
The probiotic yoghurt will be prepared using lactobacillus NN20 isolated from Kimere (a traditional fermented food product) consumed in eastern part of kenya
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
10 Years
ALL
Yes
Sponsors
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University of Western Ontario, Canada
OTHER
Technical University of Kenya
OTHER
Responsible Party
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Nicholas Nduti
Food scientist
Principal Investigators
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Gregor Reid, PhD
Role: STUDY_DIRECTOR
Lawson health Research Institute- st Joseph hospital London Ontario
Nicholas Nduti, PhD expected
Role: PRINCIPAL_INVESTIGATOR
Technical University of Kenya
Locations
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Embu
Embu, Embu County, Kenya
Countries
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Central Contacts
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Related Links
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Other Identifiers
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P446/08/2013
Identifier Type: -
Identifier Source: org_study_id
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