Mycotoxins in Mothers Milk in Israel

Study Overview
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Brief Summary
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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.

Detailed Description
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Fungi from the genus Aspergillus, Penicillium, Fusarium and Alternaria can synthesize toxins. These may be carcinogenic, immunotoxic or endocrine disruptors. In this trial, Zearalenone, Deoxynivalenol, T-2 toxin, Fumonisin B1, Fumonisin B2, Aflatoxin M1, Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2, Ochratoxin A, HT-2 toxin, De-epoxy-deoxynivalanol presence and quantity will be assessed in mother's milk. Another purpose is to try to pinpoint at the source(s) of contamination.

Official Title
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Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: exposure to mycotoxins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 and above. Pregnant women after week 37 intending to breastfeed. Women breastfeeding. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| breastfeeding mothers<br>pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months | Other: exposure to mycotoxins<br>* self-report eating questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycotoxins in breastmilk | To measure mycotoxins and mycotoxins metabolites levels in breast milk | approx. 6 months after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Source of contamination | To evaluate the source of the contamination by correlation to food intake and life habits questionnaires. | approx. one year after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mycotoxins