Effect of Consuming a Combination of Probiotic Strains and a Combination of Plant Extracts and a Probiotic Strain on the Production and Nutritional Composition of Breast Milk

Not Applicable

Completed

• Conditions: Breast Milk Expression
• Interventions: Dietary Supplement: Voluntas-Prob; Dietary Supplement: Prob-milk; Dietary Supplement: Placebo

• Registration Number: NCT04639232
• Lead Sponsor: Biosearch S.A.

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-20
• Study Start: 2021-01-30
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

1. Lactating women between 18 and 45 years old, who have given birth to a healthy baby at term (born between 37 and 42 weeks).
2. Who have the perception of having little volume of milk or a nutritional composition of milk that is not adequate for their baby
3. That they are between week 2 and week 6 of breastfeeding, and that at the time of beginning the study they are not supplementing with formula milk the feeding of their baby.
4. That they have the firm intention of breastfeeding for 28 more days.
5. Women who agree to participate and have read, understood and signed the informed consent

Exclusion Criteria

1. Suffering from any disease that may hinder or prevent breastfeeding
2. Being currently consuming or having consumed in the two weeks prior to the study a probiotic or a supplement with plant extracts.
3. Being consuming any drug that can alter the volume or composition of breast milk.
4. Have an allergy to any antibiotics or peanuts
5. Have an allergy to any of the components of the products under study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voluntas-Prob	Voluntas-Prob	Volunteers will take 6 capsules per day for 28 days a capsule containing the combination of plant extracts and the inactivated probiotic strain
Prob-milk	Prob-milk	Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination.
Control group	Placebo	Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin.

Primary Outcome Measures

Name	Time	Method
Volume of breast milk	28 days	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.
Microbiota of breast milk	28 days	Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk

Secondary Outcome Measures

Name	Time	Method
Baby's anthropometric measures_height	28 days	Height (cm) of the baby at baseline, 14 days and 28 days.
Baby feces microbiota	28 days	Presence of Lactobacillus spp, Bifidobacterium spp., Streptococcus spp. Staphylococcus spp, Bacteroides spp, E. coli spp, Clostridium spp in baby faeces
Data about the intestinal health of the baby_color of the faeces	28 days	Data about color of the feces (yellow, mustard, brown, grey, or green)
Measurement of IL-8 in breast milk	28 days	Analysis of the concentration of IL-8 (pg/mL) in breast milk
Measurement of IgA in breast milk	28 days	Analysis of the concentration of IgA (ug/mL) in breast milk
Baby's anthropometric measures_weight	28 days	Weight (kg) of the baby at baseline, 14 days and 28 days.
Infantile colick symptoms	28 days	Presence of infantile colick defined as vigorous and inconsolable crying for more than 3 hours a day for at least 3 weeks
Nutritional composition of breast milk	28 days	Analysis of the content of proteins, fatty acids profile and total fat content, and iron and calcium content in breast milk
Data about the intestinal health of the baby_stool frequency	28 days	Data about stool frequency (times per day)
Baby's anthropometric measures_BMI	28 days	BMI (kg/m2) of the baby at baseline, 14 days and 28 days.
Data about the intestinal health of the baby_consistency of the feces	28 days	Data about consistency of the feces (hard lumps, sausage with cracks, soft sausage, mushy (like porridge),or watery)
Data about sleep parameters of the baby	28 days	Hours of night sleeping per day and hours of total sleeping during the day

Trial Locations

Locations (1)

Centro de Salud de Maracena; 🇪🇸 Maracena, Granada, Spain