Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya

Conditions
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Aflatoxicosis

Intervention / Treatment
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* Dietary Supplement: probiotic yoghurt


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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic yoghurt<br>the subject will be given 200ml of yogurt daily for 28 days | Dietary Supplement: probiotic yoghurt<br>* The probiotic yoghurt will be prepared using lactobacillus NN20 isolated from Kimere (a traditional fermented food product) consumed in eastern part of kenya<br>* Other names: NN20;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aflatoxin M1 in urine | urine samples will be collected from the subjects every morning before the first meal for a period of 28 days. Test of aflatoxin M1 the bio maker of aflatoxicosis will be carried in the samples. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albumin adduct in blood | baseline blood samples will be collected before intervetion and at the end of the study. test of albumin adduct in blood will be carried. this a bio maker of aflatoxicosis in blood | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, Yoghurt, NN20