AflatoxicosisNCT02041026
Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya
A study testing probiotic yoghurt in people with Aflatoxicosis, run by Technical University of Kenya at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Aflatoxicosis
- What is being tested?
- probiotic yoghurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKenya
- Study dates
- Feb 2014to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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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Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aflatoxicosis
- Being tested
- probiotic yoghurt
- Keywords
- probiotic, Yoghurt, NN20
- Medical subject headings
- Aflatoxin Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic yoghurtDietary supplement
Also called NN20
The probiotic yoghurt will be prepared using lactobacillus NN20 isolated from Kimere (a traditional fermented food product) consumed in eastern part of kenya
| Study group | Role | What they receive |
|---|---|---|
| probiotic yoghurt | Experimental | the subject will be given 200ml of yogurt daily for 28 days Receives: Dietary Supplement: probiotic yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AflatoxicosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Kenya
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Principal investigator, Nicholas Nduti, Technical University of Kenya
- Investigators
- Gregor Reid, PhD, Study director, Lawson health Research Institute- st Joseph hospital London OntarioNicholas Nduti, PhD expected, Principal investigator, Technical University of Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041026
- Sponsor's protocol ID
- P446/08/2013
- Status last verified
- Jan 2014
- First submitted
- 17 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Probiotic Yoghurt on Reducing the Levels of Aflatoxin B1 Toxin Among the School Children in Eastern Kenya
- ClinicalTrials.gov ID
- NCT02041026
- Acronym / sponsor ID
- P446/08/2013
- Conditions
- Aflatoxicosis
- Keywords
- probiotic, Yoghurt, NN20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Technical University of KenyaUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| probiotic yoghurt | Experimental | Dietary Supplement: probiotic yoghurtthe subject will be given 200ml of yogurt daily for 28 days |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic yoghurtAlso: NN20The probiotic yoghurt will be prepared using lactobacillus NN20 isolated from Kimere (a traditional fermented food product) consumed in eastern part of kenya | Dietary supplement | probiotic yoghurt |
Primary outcome
Aflatoxin M1 in urine
Time frame: 28 days
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.
1 secondary outcome
Albumin adduct in blood
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- related infomationLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregor Reid, PhD study director
Lawson health Research Institute- st Joseph hospital London Ontario
Nicholas Nduti, PhD expected principal investigator
Technical University of Kenya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic yoghurt in people with Aflatoxicosis, run by Technical University of Kenya at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Nduti, PhD (expected) (+254 7213356, nnduti@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aflatoxin M1 in urine (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.