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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2021

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.

Interventions

  • Dietary Supplement: Placebo
    • Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
  • Dietary Supplement: Prob-milk
    • Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
  • Dietary Supplement: Voluntas-Prob
    • Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.

Arms, Groups and Cohorts

  • Placebo Comparator: Control group
    • Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin.
  • Experimental: Prob-milk
    • Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination.
  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • Volume of breast milk
    • Time Frame: 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
    • Time Frame: 28 days
    • Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Breastfeeding mothers

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Biosearch S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ruth Blanco Rojo, PhD, Principal Investigator, Biosearch S.A.
  • Overall Contact(s)
    • Ruth Blanco Rojo, PhD, +34913802973, rblanco@biosearchlife.com

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