Clinical trial NCT05371106: Mycotoxins in Mothers Milk in Israel
Official title: Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breastfeeding
Keywords: mycotoxins
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-05-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mycotoxins in breastmilk
timeFrame: approx. 6 months after recruitment
Secondary outcomes:
measure: Source of contamination
timeFrame: approx. one year after recruitment
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Shamir (Assaf Harofeh) Medical Center
name: Elkana Kohn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.