BreastfeedingNCT05371106
Mycotoxins in Mothers Milk in Israel
An observational study of Breastfeeding, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- exposure to mycotoxins
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2020to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months
Who may be able to join
- Women aged 18 and above.
- Pregnant women after week 37 intending to breastfeed.
- Women breastfeeding.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Tsrifin, 70300
Mati Berkovitch, Prof., (972)89779152, mberkovitch@shamir.gov.il
Ariela M Hazan, BSc, (972)89778465, arielah@shamir.gov.il
About this study
Official title: Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life
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.
Read the 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.
- Conditions
- Breastfeeding
- Being tested
- exposure to mycotoxins
- Keywords
- mycotoxins
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to mycotoxinsOther
self-report eating questionnaire
| Study group | Role | What they receive |
|---|---|---|
| breastfeeding mothers | pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months Receives: Other: exposure to mycotoxins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycotoxins in breastmilk
To measure mycotoxins and mycotoxins metabolites levels in breast milk
Measured: approx. 6 months after recruitment
Secondary outcomes (1)
Source of contamination
To evaluate the source of the contamination by correlation to food intake and life habits questionnaires.
Measured: approx. one year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elkana Kohn, Ph.D., Principal investigator, Shamir (Assaf Harofeh) Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371106
- Sponsor's protocol ID
- 224-20-ASF
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be shared with researchers
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.
PubMed 19875698Tesfamariam 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.
PubMed 31694387Warth 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.
PubMed 27300310El-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.
PubMed 21864634
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life
- ClinicalTrials.gov ID
- NCT05371106
- Acronym / sponsor ID
- 224-20-ASF
- Conditions
- Breastfeeding
- Keywords
- mycotoxins
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breastfeeding mothers | – | Other: exposure to mycotoxinspregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months
Key inclusion criteria (3 listed)
- Women aged 18 and above.
- Pregnant women after week 37 intending to breastfeed.
- Women breastfeeding.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to mycotoxinsself-report eating questionnaire | Other | breastfeeding mothers |
Primary outcome
Mycotoxins in breastmilk
Time frame: approx. 6 months after recruitment
To measure mycotoxins and mycotoxins metabolites levels in breast milk
1 secondary outcome
Source of contamination
Time frame: approx. one year after recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 19875698Wild 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.
- Background: PubMed 31694387Tesfamariam 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.
- Background: PubMed 27300310Warth 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.
- Background: PubMed 21864634El-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.
- Individual participant dataSharing planned: Yes. The study protocol will be shared with researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elkana Kohn, Ph.D. principal investigator
Shamir (Assaf Harofeh) Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elkana Kohn, Ph.D. (972-8-9772181, elkanak@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycotoxins in breastmilk (time frame: approx. 6 months after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371106, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.