The objective of this trial is to evaluate the effect of the consumption of a combination of probiotic strains (Prob-milk) and of a combination of plant extracts plus an inactivated probiotic strain (VoluntasProb) on the production volume and the nutritional composition and the microbiota. of breast milk in lactating women.
Previous studies have shown the galactogogue effect of fenugreek, fennel, and milk thistle. However, to date no study has considered the evaluation of all three extracts. Additionally, certain probiotic strains of Lactobacillus and Bifidobacterium also appear to increase milk production in animal studies. The objective of this trial is to evaluate the effect of the consumption of a combination of probiotic strains (Prob-milk) and of a combination of plant extracts plus an inactivated probiotic strain (VoluntasProb) on the production volume and the nutritional composition and the microbiota. of breast milk in lactating women. This is a preliminary study whose purpose is to gather information for future studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
58
Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
Centro de Salud de Maracena
Maracena, Granada, Spain
Volume of breast milk
The volume of breast milk production will be measured as the difference in weight in grams of the child before and after the first and last feeding of the day, measured on two consecutive days. It should be collected on the first two days before starting treatment and two days in a row separated by one week during treatment.
Time frame: 28 days
Microbiota of breast milk
Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk
Time frame: 28 days
Nutritional composition of breast milk
Analysis of the content of proteins, fatty acids profile and total fat content, and iron and calcium content in breast milk
Time frame: 28 days
Measurement of IL-8 in breast milk
Analysis of the concentration of IL-8 (pg/mL) in breast milk
Time frame: 28 days
Measurement of IgA in breast milk
Analysis of the concentration of IgA (ug/mL) in breast milk
Time frame: 28 days
Baby feces microbiota
Presence of Lactobacillus spp, Bifidobacterium spp., Streptococcus spp. Staphylococcus spp, Bacteroides spp, E. coli spp, Clostridium spp in baby faeces
Time frame: 28 days
Baby's anthropometric measures_weight
Weight (kg) of the baby at baseline, 14 days and 28 days.
Time frame: 28 days
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Baby's anthropometric measures_height
Height (cm) of the baby at baseline, 14 days and 28 days.
Time frame: 28 days
Baby's anthropometric measures_BMI
BMI (kg/m2) of the baby at baseline, 14 days and 28 days.
Time frame: 28 days
Data about the intestinal health of the baby_stool frequency
Data about stool frequency (times per day)
Time frame: 28 days
Data about the intestinal health of the baby_color of the faeces
Data about color of the feces (yellow, mustard, brown, grey, or green)
Time frame: 28 days
Data about the intestinal health of the baby_consistency of the feces
Data about consistency of the feces (hard lumps, sausage with cracks, soft sausage, mushy (like porridge),or watery)
Time frame: 28 days
Data about sleep parameters of the baby
Hours of night sleeping per day and hours of total sleeping during the day
Time frame: 28 days
Infantile colick symptoms
Presence of infantile colick defined as vigorous and inconsolable crying for more than 3 hours a day for at least 3 weeks
Time frame: 28 days