Considering the importance of aflatoxin M1 toxin and its role in human health as well as the effects of its transfer from breast milk to infant, the aim of this study was to investigate the effect of probiotic supplementation on the amount of aflatoxin M1 toxin in breast milk.
Design
This study will be performed by phase 2 double-blind clinical trial. Forty breastfeeding mothers with full-term and healthy 2 to 4-month-old infants will be randomly selected and then randomly divided (using a random number table) into two groups of 20 (probiotic supplement and placebo). At the beginning of the study, the amount of aflatoxin in breast milk will be measured. Then, for 1 month, they will take 2 probiotic supplements or placebo daily (after lunch and dinner).
Settings and conduct
This study will be performed by a double-blind clinical trial. Forty breastfeeding mothers with full-term and healthy 2-4-month-old infants referred to Shahid Shamli Abadan Pediatric Clinic will be randomly selected and divided into two groups of 20 (probiotic supplement and placebo). At the beginning, the milk sample will be prepared by the mother herself using a manual milking machine in a sterile plastic container of 10-15 ml. The collected milk samples will be immediately transferred to the laboratory in the cold chain and in the freezer at -20 ° C.will be maintained until analysis. The ELISA method is used to measure aflatoxin M1. Then they will take 2 probiotic supplements or a placebo (daily after lunch and dinner) for 1 month.
Participants/Inclusion and exclusion criteria
inclusion criteria :
Breastfeeding mothers with babies 2 to 4 months
No chronic diseases
Exclusion criteria:
Mothers with chronic diseases
Intervention groups
two groups (probiotic supplement and placebo). Then they will take 2 probiotic supplements or a placebo daily for 1 month.
Main outcome variables
Decreased aflatoxin M1 in breast milk
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200326046868N2
Registration date:2020-09-21, 1399/06/31
Registration timing:prospective
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Reza Malihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7800
Email address
r.malihi@abadanums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-25, 1399/07/04
Expected recruitment end date
2020-09-30, 1399/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotic supplementation on aflatoxin M1 levels in breast milk
Public title
The effect of probiotic supplementation on breast milk aflatoxin M1
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Breastfeeding mothers with babies 2 to 4 months
NO chronic diseases
Exclusion criteria:
non breastfeeding mother without babies 2 to 4 months
mothers with chronic disease
Age
From 20 years old to 39 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this double blind study, Researchers and mothers have no information about the type of drug or placebo. Allocate mothers to two intervention and control groups so that the list of subjects studied will be randomly generated by a computer.The intervention and control group will be placed inside the numbered envelopes and will be sealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the participants in the trial are not aware of which probiotics or drugs they are taking.Probiotics and placebo are given to the case and control group by a third peson who is a clinical attentive
Placebo
Used
Assignment
Other
Other design features
In this study, we have two groups of control and case, which are given probiotics to the case group and placebo to the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Abadan School of Medical Sciences
Street address
Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city.
City
Abadan
Province
Khouzestan
Postal code
631911154 061
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.ABADANUMS.REC.1398.078
Health conditions studied
1
Description of health condition studied
Aflatoxin contamination
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of aflatoxin M1 in breast milk
Timepoint
Measuring the amount of flatoxin in breast milk At the beginning of the study and then for 1 month according to the divided group, they will take 2 probiotic supplements or placebo (daily after lunch and dinner). After the intervention, the amount of aflatoxin in breast milk will be measured again.
Method of measurement
At the beginning of the study, the milk sample will be prepared by the mother herself using a manual milking machine in a sterile plastic container of 10-15 ml. The collected milk samples will be immediately transferred to the laboratory in the cold chain and in the freezer at -20 ° C. C will be maintained until analysis. ELISA is used to measure aflatoxin M1.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will take 2 probiotic supplements daily (after lunch and dinner) for 1 month. It is worth mentioning that in this study, several species of probiotic supplements (FamiLact co, Tehran, Iran) will be used, which include 7 stable and frozen strains: Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobactidum, Streptococcus thermophilus This supplement is an oral capsule with Kant CFU 109.
Category
Treatment - Drugs
2
Description
Control group: They will take 2 probiotic supplements daily (after lunch and dinner) for 1 month. The company will provide researchers with similar bacteria-free materials as a placebo.