Assessing mycotoxins in mothers' milk in Israel
Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life
This study looks at whether harmful toxins from mold are found in the breast milk of mothers in Israel to understand any health risks for breastfeeding babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 1 site (Ẕerifin) |
| Trial ID | NCT05371106 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the presence of harmful mycotoxins in the breast milk of women in Israel. It focuses on identifying toxins produced by certain fungi that may contaminate food and subsequently enter the human body. The study will analyze various mycotoxins, including Aflatoxins and Fumonisins, to determine their levels in mothers' milk and investigate potential sources of contamination. By understanding the prevalence of these toxins, the study seeks to highlight health risks associated with breastfeeding in contaminated environments.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and above who are either pregnant after week 37 or currently breastfeeding.
Not a fit: Patients who are taking medications that affect milk production or are contraindicated during breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety guidelines for breastfeeding mothers regarding food consumption and toxin exposure.
How similar studies have performed: While studies on mycotoxins exist, this specific focus on mothers' milk in Israel is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ẕerifin
- Assaf Harofeh Medical Center — Ẕerifin, Israel (Recruiting)
Study contacts
- Principal investigator: Elkana Kohn, Ph.D. — Shamir (Assaf Harofeh) Medical Center
- Study coordinator: Elkana Kohn, Ph.D.
- Email: elkanak@shamir.gov.il
- Phone: 972-8-9772181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.