Mycotoxins in Mothers Milk in Israel

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05371106

Enrollment

150

Registered

2022-05-12

Start date

2020-09-01

Completion date

2028-12-31

Last updated

2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

mycotoxins

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.

Interventions

OTHERexposure to mycotoxins

self-report eating questionnaire

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactElkana Kohn, Ph.D.

elkanak@shamir.gov.il972-8-9772181

Backup ContactAriela M Hazan, BSc

arielah@shamir.gov.il972-8-9778465

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026