Mycotoxins in Mothers Milk in Israel

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371106
• Other study ID #: 224-20-ASF
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Assaf-Harofeh Medical Center
• Contact: Elkana Kohn, Ph.D.
• Phone: 972-8-9772181
• Email: elkanak[@]shamir.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• exposure to mycotoxins
self-report eating questionnaire

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mycotoxins in breastmilk	To measure mycotoxins and mycotoxins metabolites levels in breast milk	approx. 6 months after recruitment
Secondary	Source of contamination	To evaluate the source of the contamination by correlation to food intake and life habits questionnaires.	approx. one year after recruitment