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Mycotoxins in Mothers Milk in Israel

S

Shamir Medical Center (Assaf-Harofeh)

Status

Enrolling

Conditions

Breastfeeding

Treatments

Other: exposure to mycotoxins

Study type

Observational

Funder types

Other

Identifiers

NCT05371106
224-20-ASF

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Elkana Kohn, Ph.D.; Ariela M Hazan, BSc

Data sourced from clinicaltrials.gov

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