Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT05371106
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2022-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mycotoxins in Mothers Milk in Israel
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Study Overview
Official Title:
Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: