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NCT Number: NCT05371106

Mycotoxins in Mothers Milk in Israel

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.

Recruiting

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location status: Recruiting

Location contact

Ariela Hazan

SUB_INVESTIGATOR

Ariela M Hazan, BSc

CONTACT

[email protected]

(972)89778465

Elkana Kohn, Dr.

SUB_INVESTIGATOR

Mati Berkovitch, Prof.

CONTACT

[email protected]

(972)89779152

Mati Berkovitch, Prof.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exposure to mycotoxins

Other

self-report eating questionnaire

Primary outcomes

  1. Mycotoxins in breastmilk

    Time frame: approx. 6 months after recruitment

    To measure mycotoxins and mycotoxins metabolites levels in breast milk

Secondary outcomes

  1. Source of contamination

    Time frame: approx. one year after recruitment

    To evaluate the source of the contamination by correlation to food intake and life habits questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariela M Hazan, BSc

CONTACT

[email protected]

972-8-9778465

Elkana Kohn, Ph.D.

CONTACT

[email protected]

972-8-9772181

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
May 12, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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