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

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.

Study Overview

• Status: Recruiting
• Conditions: Breastfeeding
• Intervention / Treatment: Other: exposure to mycotoxins

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Elkana Kohn, Ph.D.; Phone Number: 972-8-9772181; Email: elkanak@shamir.gov.il
• Study Contact Backup: Name: Ariela M Hazan, BSc; Phone Number: 972-8-9778465; Email: arielah@shamir.gov.il

Study Locations

• Israel
  • Ẕerifin, Israel, 70300
    • Recruiting
    • Assaf Harofeh Medical Center
    • Contact: Mati Berkovitch, Prof.; Phone Number: (972)89779152; Email: mberkovitch@shamir.gov.il
    • Contact: Ariela M Hazan, BSc; Phone Number: (972)89778465; Email: arielah@shamir.gov.il
    • Sub-Investigator: Mati Berkovitch, Prof.
    • Sub-Investigator: Ariela Hazan
    • Sub-Investigator: Elkana Kohn, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
breastfeeding mothers; pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months	Other: exposure to mycotoxins; self-report eating questionnaire

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Elkana Kohn, Ph.D., Shamir (Assaf Harofeh) Medical Center

Publications and helpful links

General Publications

• Wild CP, Gong YY. Mycotoxins and human disease: a largely ignored global health issue. Carcinogenesis. 2010 Jan;31(1):71-82. doi: 10.1093/carcin/bgp264. Epub 2009 Oct 29.
• Tesfamariam K, De Boevre M, Kolsteren P, Belachew T, Mesfin A, De Saeger S, Lachat C. Dietary mycotoxins exposure and child growth, immune system, morbidity, and mortality: a systematic literature review. Crit Rev Food Sci Nutr. 2020;60(19):3321-3341. doi: 10.1080/10408398.2019.1685455. Epub 2019 Nov 6.
• Warth B, Braun D, Ezekiel CN, Turner PC, Degen GH, Marko D. Biomonitoring of Mycotoxins in Human Breast Milk: Current State and Future Perspectives. Chem Res Toxicol. 2016 Jul 18;29(7):1087-97. doi: 10.1021/acs.chemrestox.6b00125. Epub 2016 Jun 28.
• El-Tras WF, El-Kady NN, Tayel AA. Infants exposure to aflatoxin M(1) as a novel foodborne zoonosis. Food Chem Toxicol. 2011 Nov;49(11):2816-9. doi: 10.1016/j.fct.2011.08.008. Epub 2011 Aug 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: May 8, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: mycotoxins
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: 224-20-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol will be shared with researchers
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: interested colleagues
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No