Mycotoxins in Mothers Milk in Israel
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: exposure to mycotoxins.
- Who it may be relevant to
- Registry conditions: Breastfeeding. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life
Overview
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.
Interventions
- Other exposure to mycotoxins
self-report eating questionnaire
Primary outcome measures
- Mycotoxins in breastmilk [Time frame: approx. 6 months after recruitment]
Secondary outcome measures (1)
- Source of contamination [Time frame: approx. one year after recruitment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Assaf Harofeh Medical Center — Ẕerifin
Publications
- 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. PMID 19875698
- 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. PMID 31694387
- 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. PMID 27300310
- 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. PMID 21864634
Identifiers
NCT: NCT05371106 · 224-20-ASF