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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201110181197N12

Enrollment

Registered

2011-10-31

Start date

2011-10-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactating mothers. Care and examination of lactating mother

Interventions

Intervention 1: Intervention= probiotic capsule(112×106), 4 weeks, twice a day. Intervention 2: Control group= placebo, 4 weeks, twice a day.

Treatment - Drugs

Placebo

Intervention= probiotic capsule(112×106), 4 weeks, twice a day

Control group= placebo, 4 weeks, twice a day

Eligibility

Sex/Gender

Female

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Isolation and comparison of supplemented bacteria before and after probiotic supplementation in study groups. Timepoint: onset and end of study. Method of measurement: PCR.	—

Secondary

Measure	Time frame
Determination and comparison of breast milk IgA, TGFß1, TGFß2 levels in breast milk before and after probiotic supplementation in two groups. Timepoint: onset and end of study. Method of measurement: IgA= Nephelometry, TGFß1, TGFß2 = 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).	—

Measure

Time frame

Determination and comparison of breast milk IgA, TGFß1, TGFß2 levels in breast milk before and after probiotic supplementation in two groups. Timepoint: onset and end of study. Method of measurement: IgA= Nephelometry, TGFß1, TGFß2 = 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).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Reza Mahdavi

Tabriz University of Medical Sciences

mahdavirez@hotmail.com+98 914 113 0310

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026