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
Eighty lactating women admitted to Tabriz health centers who entered to the study based on the inclusion criteria will be randomly divided in probiotic supplementation and placebo groups. The mothers in intervention group will receive one probiotic capsule after breakfast and another one after dinner and mothers in placebo group will receive placebo for 4 weeks. Anthropometric and dietary intake information of mothers and infants will be collected before and after intervention. For determining breast milk probiotic content, IgA, TGFβ1, TGFβ2 and total antioxidant and MDA, zinc, selenium, copper, iron, magnesium and calcium concentrations, 15 cc of breast milk will be collected in a sterile tube by manual expression using sterile gloves in the morning after discarding 5cc. Previously, nipples and mammary areola will be cleaned with soap and sterile water and soaked in chlorhexidine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110181197N12
Registration date:2011-10-31, 1390/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-31, 1390/08/09
Registrant information
Name
Reza Mahdavi
Name of organization / entity
Faculty of Health & Nutrition, Tabriz UniV. of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7584
Email address
mahdavir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition research center,Agricultural Biotechnology Research Institute of West and North-West Iran
Expected recruitment start date
2011-10-21, 1390/07/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Prevention
Inclusion/Exclusion 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
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Added at : breast milk zinc, selenium, copper, iron, magnesium and calcium concentrations
Secondary trial Id
Added at : onset and end of study
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Postal code
Approval date
2011-10-21, 1390/07/29
Ethics committee reference number
9041
Health conditions studied
1
Description of health condition studied
Lactating mothers
ICD-10 code
Z39
ICD-10 code description
Care and examination of lactating mother
Primary outcomes
1
Description
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 outcomes
1
Description
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
2
Description
Determination and comparison of total antioxidant capacity and MDA levels in breast milk before and after probiotic supplementation in two groups