Clinical trial NCT02041026: Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya
Official title: Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aflatoxicosis
Keywords: probiotic
Yoghurt
NN20
Lead sponsor: Technical University of Kenya
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2014-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We hypothesis that intake of probiotic yogurt reduces absorption of AFB1 in the gut and subsequently reduce AFM1 and aflatoxins adduct, the biomarker in human urine and blood respectively. We have demonstrated that yogurt made using weisella cibiria NN20 isolated from fermented dough made from pearl millet in eastern part of Kenya sequestered upto 42% of aflatoxin available in our invitro texts.

Detailed description: In both the developed and developing world, humans are continuously exposed to a plethora of environmental toxins, both in nature and as the result of anthropomorphic activity. Aflatoxin B1, one such example, is one of the most toxic substances known to man, but it is all around us and can be found in our food, and especially cereals which form over 70% of Kenya staple food.

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.

Eligibility criteria: Inclusion Criteria:Participants will be recruited from an identified primary school and parental/ legal guardian consent will be required as well as assent from the child. The primary school has been identified with the help of Ministry of agriculture home economics extension officer. The criterion of selecting the primary school is accessibility from Embu ATC where yogurt will be produced and the area which is prone to aflatoxin B1. Children between the ages of 6 and 10 will be enrolled in the study.

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Exclusion Criteria:Children would be excluded if they are already consuming fermented milk products or are lactose intolerant.

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Primary outcomes:
measure: Aflatoxin M1 in urine
timeFrame: 28 days
Secondary outcomes:
measure: Albumin adduct in blood
timeFrame: 28 days
Other outcomes:
measure: microbiota in the stool
timeFrame: 28 days
Locations:
city: Embu
country: Kenya
facility: Embu
state: Embu County
Study officials:
affiliation: Lawson health Research Institute- st Joseph hospital London Ontario
name: Gregor Reid, PhD
role: STUDY_DIRECTOR
affiliation: Technical University of Kenya
name: Nicholas Nduti, PhD expected
role: PRINCIPAL_INVESTIGATOR
References: