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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02041026
• Other study ID #: P446/08/2013
• Status: Not yet recruiting
• Phase: N/A
• First received: January 17, 2014
• Last updated: January 17, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: January 2014
• Source: Technical University of Kenya
• Contact: Nicholas Nduti, PhD (expected)
• Phone: +254 7213356
• Email: nnduti[@]uwo.ca
• Is FDA regulated: No
• Health authority: Kenya: Kenyatta national hospital/ University of Nairobi ethics review boardKenya: Technical university of KenyaKenya: Embu Agriculture training center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

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.

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aflatoxicosis

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Kenya	Embu	Embu	Embu County

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Kenya	University of Western Ontario, Canada

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	microbiota in the stool	wewill analyze the intestinal microbiota of the children and to determine if consumption of a probiotic yogurt has a significant effect on the microbiota composition.	28 days	No
Primary	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	No
Secondary	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	No

External Links

•   related infomation