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The effects of Synbiotic on minerals

The effects of Synbiotic supplementation on blood and milk minerals and trace elements of lactating mothers

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181020041387N2
Enrollment
80
Registered
2024-06-28
Start date
2018-04-04
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Lactating mothers. Encounter for care and examination of lactating mother

Interventions

Intervention 1: Intervention group: Lactating mothers took one capsule of LactoFem including 109 CFU of probiotics (Lactobacillus fermentum, Lactobacillus plantarum, Lactobacillus acidophilus, Lactoba

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Mothers who have 1-2 months old infants Mothers who have exclusively breast fed infants Mothers aged 18-35 years old. Mothers who have Infants born in more than 36 weeks of gestational age Mothers whom their infants birth weight was more than 2500 gram.

Exclusion criteria

Exclusion criteria: Mothers with chronic disorders Taking Antibiotics 2 weeks prior to the study by mothers. Taking any other multivitamin and mineral supplements except that is administered by the health team for all lactating mothers. History of hospitalization in infants

Design outcomes

Primary

MeasureTime frame
Plasma Calcium (Ca) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Milk Calcium (Ca) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Plasma Magnesium (Mg) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Milk Magnesium (Mg) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Plasma Iron (Fe) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Milk Iron (Fe) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Plasma Copper (Cu) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Milk Copper (Cu) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Plasma Manganese (Mn) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Milk Manganese (Mn) Level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Milk Zinc (Zn) level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Plasma Zinc (Zn) level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.;Plasma Aluminium (Al) level. Timepoint: Before intervention and one month after intervention. Method of measurement: Atomic absorption spectrometry.

Secondary

MeasureTime frame
Infant weight for age Z-score. Timepoint: Before intervention, 1 month after intervention, at the age of 6 and 12 months old. Method of measurement: Scale, weight for age z-score chart.;Infant height for age Z-score. Timepoint: Before intervention, 1 month after intervention, at the age of 6 and 12 months old. Method of measurement: Meter, Height for age z-score chart.;Infant head circumference for age Z-score. Timepoint: Before intervention, 1 month after intervention, at the age of 6, 12 and 36 months old. Method of measurement: Meter, head circumference for age z-score chart.;Infant wheezing episodes. Timepoint: At the age of 12 months. Method of measurement: Parents statement.;Infant Hospitalization. Timepoint: At the age of 12 months old. Method of measurement: Parents' statement.;Bronchodilator inhaler usage. Timepoint: At the age of 12 months old. Method of measurement: Parents' statement.;Infants' taking antibiotics. Timepoint: At the age of 12 months old. Method of measurement: Parents' statement.;Infants' constipation. Timepoint: before and after intervention. Method of measurement: Parents' statement.;Mothers' constipation. Timepoint: At the base of intervention, a month after intervention. Method of measurement: Mothers' statement.;Infants' Eczema. Timepoint: At the base of intervention, a month after intervention. Method of measurement: Mothers' statement.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Zalfa Modarresi

Yazd University of Medical Sciences

dr.modarres@gmail.com+98 35 3822 4000

Outcome results

None listed

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