]>
IRCT201110181197N12 IRCT 2011-10-31 Nutrition Research Center, Tabriz University of Medical Sciences Effect of probiotic supplementation on presence of supplemented bacteria in breast milk, some of milk’s immune and oxidative factors, mothers’ nutritional status and infants’ growth Effect of probiotic supplementation on presence of supplemented bacteria in breast milk, some of milk’s immune and oxidative factors, zinc, selenium, copper, iron, magnesium and calcium concentrations in breast milk, mothers’ nutritional status and infants’ growth 2011-10-21 anticipated 80 Complete https://irct.ir/trial/407 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A Lactating mothers. Intervention 1: Intervention= probiotic capsule(112×106), 4 weeks, twice a day. Intervention 2: Control group= placebo, 4 weeks, twice a day.
public Dr Reza Mahdavi
Health and Nutrition Faculty- Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) +98 914 113 0310 mahdavirez@hotmail.com Tabriz University of Medical Sciences scientific Leila Nikniaz
Health and Nutrition faculty- Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) +98 914 419 1384 nikniaz_l@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The criteria for inclusion of mothers 1) healthy mothers without disease based on medical history2) having exclusively breastfed infants aged 90 days 3) having exclusively breastfed infants with normal birth weight 4)having exclusively breastfed infants without any chronic disease 5)having exclusively breastfed infants who were full term 6) having second order infants. The criteria for exclusion of mothers 1)mothers consuming antibiotic before and/or in study period 2) mothers who have fever and mastitis before and/or in study period 3)mothers consuming probiotic products 4)mothers consuming antioxidant supplements 18 years 35 years Female Z39 Care and examination of lactating mother Treatment - Drugs Placebo Intervention= probiotic capsule(112×106), 4 weeks, twice a day Control group= placebo, 4 weeks, twice a day Isolation and comparison of supplemented bacteria before and after probiotic supplementation in study groups. Timepoint: onset and end of study. Method of measurement: PCR. Determination and comparison of breast milk IgA, TGFβ1, TGFβ2 levels in breast milk before and after probiotic supplementation in two groups. Timepoint: onset and end of study. Method of measurement: IgA= Nephelometry, TGFβ1, TGFβ2 = ELISA. Determination and comparison of total antioxidant capacity and MDA levels in breast milk before and after probiotic supplementation in two groups. Timepoint: onset and end of study. Method of measurement: antioxidant capacity = Randox kit, MDA= fluorometry. Determination and comparison of lactating mothers’ BMI, energy and macronutrient intake before and after probiotic supplementation in two groups. Timepoint: onset and end of study. Method of measurement: Food record questionnaire. Determination and comparison of infants’ anthropometric indices before and after probiotic supplementation in two groups. Timepoint: onset and end of study. Method of measurement: Weight= electronic scales, Height= Scale (SCHORR). Added at 2013-08-06: zinc, selenium, copper, iron, magnesium and calcium concentrations in breast milk. Timepoint: Added at 2013-08-06: onset and end of study. Method of measurement: Added at 2013-08-06: Atomic absorbtion (Calcium: kit). Agricultural Biotechnology Research Institute of West and North-West Iran Added at : onset and end of study Added at : breast milk zinc, selenium, copper, iron, magnesium and calcium concentrations Nutrition Research Center, Tabriz University of Medical Sciences Agricultural Biotechnology Research Institute of West and North-West Iran Approved 2011-10-21 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht street, Tabriz Tabriz Iran (Islamic Republic of)