Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2020-09-01
2028-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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breastfeeding mothers
pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months
exposure to mycotoxins
self-report eating questionnaire
Interventions
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exposure to mycotoxins
self-report eating questionnaire
Eligibility Criteria
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Inclusion Criteria
* Pregnant women after week 37 intending to breastfeed.
* Women breastfeeding.
Exclusion Criteria
* 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.
18 Years
55 Years
FEMALE
Yes
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Elkana Kohn, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Shamir (Assaf Harofeh) Medical Center
Locations
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Assaf Harofeh Medical Center
Ẕerifin, , Israel
Countries
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Central Contacts
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Facility Contacts
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Mati Berkovitch, Prof.
Role: primary
Ariela M Hazan, BSc
Role: backup
References
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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.
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.
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.
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.
Other Identifiers
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224-20-ASF
Identifier Type: -
Identifier Source: org_study_id