Mycotoxins in Mothers Milk in Israel

Recruiting

• Conditions: Breastfeeding
• Interventions: Other: exposure to mycotoxins

• Registration Number: NCT05371106
• Lead Sponsor: Assaf-Harofeh Medical Center

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 Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-05-08
• Study First Posted: 2022-05-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
breastfeeding mothers	exposure to mycotoxins	pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months

Primary Outcome Measures

Name	Time	Method
Mycotoxins in breastmilk	approx. 6 months after recruitment	To measure mycotoxins and mycotoxins metabolites levels in breast milk

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel