Clinical trial NCT04639232: 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
Official title: Multicenter, Randomized, Double-blind Parallel Group Pilot Study to Evaluate the 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Milk Expression
Keywords: Breastfeeding
Galactogogue
Plant extracts
Probiotics
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Volume of breast milk
timeFrame: 28 days
measure: Microbiota of breast milk
timeFrame: 28 days
Secondary outcomes:
measure: Nutritional composition of breast milk
timeFrame: 28 days
measure: Measurement of IL-8 in breast milk
timeFrame: 28 days
measure: Measurement of IgA in breast milk
timeFrame: 28 days
measure: Baby feces microbiota
timeFrame: 28 days
measure: Baby's anthropometric measures_weight
timeFrame: 28 days
measure: Baby's anthropometric measures_height
timeFrame: 28 days
measure: Baby's anthropometric measures_BMI
timeFrame: 28 days
measure: Data about the intestinal health of the baby_stool frequency
timeFrame: 28 days
measure: Data about the intestinal health of the baby_color of the faeces
timeFrame: 28 days
measure: Data about the intestinal health of the baby_consistency of the feces
timeFrame: 28 days
measure: Data about sleep parameters of the baby
timeFrame: 28 days
measure: Infantile colick symptoms
timeFrame: 28 days
Other outcomes:
Locations:
city: Maracena
country: Spain
facility: Centro de Salud de Maracena
state: Granada
Study officials:
affiliation: Biosearch S.A.
name: Ruth Blanco Rojo, PhD
role: PRINCIPAL_INVESTIGATOR
References: