Mycotoxins in Mothers Milk in Israel
ConditionBreastfeeding
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorAssaf-Harofeh Medical Center
About this trial
Some plant pathogen fungi may develop in grains, nuts and dry foodstuff during their storage. They secrete toxins which are very resistant and persistent.
The toxins enter the human body through the food. Women eating without their knowledge spoiled food absorb the toxin which is conveyed into their milk. In the same way, meat and dairy products can be contaminated with mycotoxins.
Toxins and their metabolites can have negative effects on pregnant women and on the fetus or infant health.
The main purpose of this trial is to assess the presence of toxins in mothers's milk.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 18 and above.
Pregnant women after week 37 intending to breastfeed.
Women breastfeeding.
Disqualifiers
Women taking drugs which influence milk production.
Women taking drugs contraindicated during breastfeeding.
Women not staying in Israel during third trimester or in the months after birth for a long period of time.
Women not wanting/able to fill up the questionnaires.
Trial population
pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
exposure to mycotoxins
Other interventionself-report eating questionnaire
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: breastfeeding mothers1 intervention
Trial outcomes
Primary outcomes
1
Mycotoxins in breastmilk
To measure mycotoxins and mycotoxins metabolites levels in breast milk
Time frame
approx. 6 months after recruitmentSecondary outcomes
1
Source of contamination
To evaluate the source of the contamination by correlation to food intake and life habits questionnaires.
Time frame
approx. one year after recruitmentSponsors and contacts
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Source ClinicalTrials.gov