Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Mycotoxins in breastmilk
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Mycotoxins in breastmilk
Time Frame: approx. 6 months after recruitment
To measure mycotoxins and mycotoxins metabolites levels in breast milk
Secondary Outcomes
- Source of contamination(approx. one year after recruitment)