NCT02041026

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

2 months

First QC Date

January 17, 2014

Last Update Submit

January 17, 2014

Conditions

Aflatoxicosis

Keywords

probioticYoghurtNN20

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Albumin adduct in blood

    28 days

Other Outcomes (1)

  • microbiota in the stool

    28 days

Study Arms (1)

probiotic yoghurt

EXPERIMENTAL

the subject will be given 200ml of yogurt daily for 28 days

Dietary Supplement: probiotic yoghurt

Interventions

probiotic yoghurtDIETARY_SUPPLEMENT

The probiotic yoghurt will be prepared using lactobacillus NN20 isolated from Kimere (a traditional fermented food product) consumed in eastern part of kenya

Also known as: NN20
probiotic yoghurt

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Embu

Embu, Embu County, Kenya

Location

Related Links

MeSH Terms

Conditions

Aflatoxin Poisoning

Condition Hierarchy (Ancestors)

MycotoxicosisPoisoningChemically-Induced Disorders

Study Officials

  • Gregor Reid, PhD

    Lawson health Research Institute- st Joseph hospital London Ontario

    STUDY DIRECTOR

  • Nicholas Nduti, PhD expected

    Technical University of Kenya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Nduti, PhD (expected)

CONTACT

+254 7213356nnduti@uwo.ca

Dr. Gregor Reid, PhD

CONTACT

+151 985 430 22gregor@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Food scientist

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 20, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

KE(1)