Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin. |
|
| Prob-milk | Experimental | Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination. |
|
| Voluntas-Prob | Experimental | Volunteers will take 6 capsules per day for 28 days a capsule containing the combination of plant extracts and the inactivated probiotic strain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Microbiota of breast milk | Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| Measurement of IL-8 in breast milk |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Breastfeeding mothers
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ruth Blanco Rojo, PhD | Biosearch S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud de Maracena | Maracena | Granada | 18200 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prob-milk | Dietary Supplement | Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life. |
|
| Voluntas-Prob | Dietary Supplement | Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life. |
|
Analysis of the concentration of IL-8 (pg/mL) in breast milk
| 28 days |
| Measurement of IgA in breast milk | Analysis of the concentration of IgA (ug/mL) in breast milk | 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 | 28 days |
| Baby's anthropometric measures_weight | Weight (kg) of the baby at baseline, 14 days and 28 days. | 28 days |
| Baby's anthropometric measures_height | Height (cm) of the baby at baseline, 14 days and 28 days. | 28 days |
| Baby's anthropometric measures_BMI | BMI (kg/m2) of the baby at baseline, 14 days and 28 days. | 28 days |
| Data about the intestinal health of the baby_stool frequency | Data about stool frequency (times per day) | 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) | 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) | 28 days |
| Data about sleep parameters of the baby | Hours of night sleeping per day and hours of total sleeping during the day | 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 | 28 days |
| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided