Recruitment

Recruitment Status
Unknown status

Summary

Conditions
Aflatoxicosis
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 6 years and 10 years
Gender
Both males and females

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 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.

Locations

Embu, Embu County
Embu, Embu County

Tracking Information

NCT #
NCT02041026
Collaborators
University of Western Ontario, Canada
Investigators
  • Study Director: Gregor Reid, PhD Lawson health Research Institute- st Joseph hospital London Ontario Principal Investigator: Nicholas Nduti, PhD expected Technical University of Kenya
  • Study Director: Gregor Reid, PhD Lawson health Research Institute- st Joseph hospital London Ontario Nicholas Nduti, PhD expected Technical University of Kenya