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IRCT20200326046868N2 IRCT 2020-09-21 Abadan University of Medical Sciences The effect of probiotic supplementation on breast milk aflatoxin M1 Evaluation of the effect of probiotic supplementation on aflatoxin M1 levels in breast milk 2020-09-25 anticipated 40 Complete https://irct.ir/trial/50987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: 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, 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 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. 2 Aflatoxin contamination. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All information can be shared When: From 2021onwards To whom: Academic researchers Conditions: Scientific-research purposes Where to obtain: Email the respondent How to obtain: via Email Comments:
public Armin Khaleghjo
Abadan School of Medical Sciences, Beginning of the 30 meters Ave, Zolfaghari street, Abadan, Iran
Abadan Iran (Islamic Republic of) 631911154 +98 61 5338 4004 drykhaleghjoo@gmail.com Abadan University of Medical Sciences scientific Armin Khaleghjo
Abadan School of Medical Sciences, Beginning of the 30 meters Ave, Zolfaghari street, Abadan, Iran
Abadan Iran (Islamic Republic of) 631911154 +98 61 5338 4004 drykhaleghjoo@gmail.com Abadan University of Medical Sciences Iran (Islamic Republic of) Breastfeeding mothers with babies 2 to 4 months NO chronic diseases 20 years 39 years Female non breastfeeding mother without babies 2 to 4 months mothers with chronic disease Treatment - Drugs Placebo 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. 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. 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. Abadan University of Medical Sciences Approved 2020-02-15 Ethics Committee of Abadan School of Medical Sciences Abadan School of Medical Sciences,Beginning of the 30 meters Ave, Zolfaghari street, Abadan city. Abadan Khouzestan Iran (Islamic Republic of)