Aflatoxicosis Clinical Trial
Official title:
Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya
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.
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.
;
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03882294 -
Probiotics and Its Associated Factors on Aflatoxin Biomarkers
|
N/A | |
| Completed |
NCT02188953 -
Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya
|
Phase 2 |