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RecruitingNCT05371106

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
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Assaf-Harofeh Medical Center · Other Government
Sex
Female
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERexposure to mycotoxinsself-report eating questionnaire

Timeline

Start date
2020-09-01
Primary completion
2027-12-31
Completion
2028-12-31
First posted
2022-05-12
Last updated
2025-12-24

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT05371106. Inclusion in this directory is not an endorsement.