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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Breast Milk Expression Behavior Breast Feeding Feeding Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud de Maracena

Maracena, Granada, 18200, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lactating women between 18 and 45 years old, who have given birth to a healthy baby at term (born between 37 and 42 weeks).
  • Who have the perception of having little volume of milk or a nutritional composition of milk that is not adequate for their baby
  • 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.
  • That they have the firm intention of breastfeeding for 28 more days.
  • Women who agree to participate and have read, understood and signed the informed consent

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. Microbiota of breast milk

    Time frame: 28 days

    Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk

Secondary outcomes

  1. 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

  2. Measurement of IL-8 in breast milk

    Time frame: 28 days

    Analysis of the concentration of IL-8 (pg/mL) in breast milk

  3. Measurement of IgA in breast milk

    Time frame: 28 days

    Analysis of the concentration of IgA (ug/mL) in breast milk

  4. 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

  5. Baby's anthropometric measures_weight

    Time frame: 28 days

    Weight (kg) of the baby at baseline, 14 days and 28 days.

  6. Baby's anthropometric measures_height

    Time frame: 28 days

    Height (cm) of the baby at baseline, 14 days and 28 days.

  7. Baby's anthropometric measures_BMI

    Time frame: 28 days

    BMI (kg/m2) of the baby at baseline, 14 days and 28 days.

  8. Data about the intestinal health of the baby_stool frequency

    Time frame: 28 days

    Data about stool frequency (times per day)

  9. 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)

  10. 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)

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2020
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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