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

Evaluation of the effect of synbiotic supplementation on blood and milk minerals and trace elements of lactating mothers.

Two arm parallel group clinical randomized trial, triple blinded, phase 3 on 80 lactating mothers. For randomization, permuted block randomization method was used.

80 lactating mothers aged 18-35 years with 1–2-month-old infants who came to Azadshahr clinic of Yazd, included in the study. Mothers were divided into two groups based on permuted block randomization. Demographic information and infants' data were obtained by a questionnaire. Samples of mothers breast milk and plasma were taken at baseline and at the end of the study for evaluation of the levels of manganese,iron,copper,calcium, magnesium in milk and blood by atomic absorption spectrometry. Weight, Height and head circumference of infants were measured at baseline, 1,6, 12 and 36-60 months after intervention. Furthermore,BMI of mothers were measured at baseline, and after intervention.

Inclusion criteria: Healthy lactating mothers aged 18-35 years old with 1-2 months old exclusive breast fed infant. Exclusion criteria: Mothers with chronic disease, taking any other multivitamin or mineral supplement, taking antibiotic less than 2 weeks prior to the study.

Intervention group: Synbiotic capsule, LactoFem (109 CFU of Lactobacillus fermentum, plantarum, acidophilus, gasseri, rhamnosus, bulgaricus, casei and Fructooligosaccharides) manufactured by Zist Takhmir company, once daily for 30 days. Control group: Placebo capsule which was similar in color, shape and taste with synbiotic capsule, manufactured by the same company, once daily for 30 days. Both groups took iron and multivitamin supplements, according to the national protocol.

Mean serum and milk levels of Mg, Mn, Ca, Fe, and Cu

In this study, the group allocation is performed through permuted block randomization at an assignment ratio of 1:1. patients were randomly divided into 2 groups: intervention group (as synbiotic supplement group) and control group (as placebo group) (named groups A and B). Group assignment was done through closed envelopes. Six of the four combinations of intervention and placebo groups A and B were determined AABB ABAB ABBA BBAA BABA BAAB (With block random assignment using a random number table). Block size was 4. For allocation concealment, the randomisation codes were kept in opaque, sealed, sequentially numbered envelopes.

Patients who enrolled in the study based on the randomization list received sealed envelopes from the secretory ward and presented them to the researcher. The researcher administered the drugs labelled as A or B according to the codes within the envelopes. Both the drugs (synbiotic supplement and the placebo capsules) were identical in appearance, shape, color, and packaging, with the only difference being the manufacturer-assigned codes. In this study, the participants, healthcare providers, the researcher doctor who provides the drug to the patients and is responsible for the follow-up of the patient-, data collectors, data and safety monitoring board and outcome assessors are not aware of the assigned groups. After the completion of the study and analysis by the statistician, the codes are determined by the manufacturing company.

Demographic data and data of primary outcomes

Up to six months after publication of the article

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Email to dr.modarres@gmail.com

Email to dr.modarres@gmail.com