Mycotoxins in Mothers Milk in Israel | NCT05371106

Studies
Mycotoxins in Mothers Milk in Israel

NCT05371106

Sponsor

Assaf-Harofeh Medical Center

Status

Recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Breastfeeding

Interventions

exposure to mycotoxins

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Apr 25, 2022

First Submission Date that Met QC Criteria

May 8, 2022

First Posted Date

May 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2025

Last Update Posted Date

Dec 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
breastfeeding mothers		pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months	Other: exposure to mycotoxins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exposure to mycotoxins	Other	self-report eating questionnaire	breastfeeding mothers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mycotoxins in breastmilk	To measure mycotoxins and mycotoxins metabolites levels in breast milk	approx. 6 months after recruitment

Secondary Outcomes

Measure	Description	Time Frame
Source of contamination	To evaluate the source of the contamination by correlation to food intake and life habits questionnaires.	approx. one year after recruitment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

pregnant women after week 37 intending to nurse or nursing mothers of infants aged 1-12 months

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elkana Kohn, Ph.D.	Contact	972-8-9772181		elkanak@shamir.gov.il
Ariela M Hazan, BSc	Contact	972-8-9778465		arielah@shamir.gov.il

Overall Officials

Name	Affiliation	Role
Elkana Kohn, Ph.D.	Shamir (Assaf Harofeh) Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofeh Medical Center	Recruiting	Ẕerifin		70300	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19875698	Background	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.
31694387	Background	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.

ID	Term
D005247	Feeding Behavior
D001519	Behavior