Breast Milk ExpressionNCT04639232
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
A study testing Prob-milk and Voluntas-Prob in people with Breast Milk Expression, run by Biosearch S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Expression
- What is being tested?
- Prob-milk and Voluntas-Prob
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Milk Expression
- Being tested
- Placebo, Prob-milk, Voluntas-Prob
- Keywords
- Breastfeeding, Galactogogue, Plant extracts, Probiotics
- Medical subject headings
- Breast Milk Expression, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary 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-milkDietary 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-ProbDietary supplement
Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin. Receives: Dietary Supplement: Placebo |
| Prob-milk | Experimental | Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination. Receives: Dietary Supplement: Prob-milk |
| 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 Receives: Dietary Supplement: Voluntas-Prob |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Microbiota of breast milk
Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk
Measured: 28 days
Secondary outcomes (12)
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
Measured: 28 days
Measurement of IL-8 in breast milk
Analysis of the concentration of IL-8 (pg/mL) in breast milk
Measured: 28 days
Measurement of IgA in breast milk
Analysis of the concentration of IgA (ug/mL) in breast milk
Measured: 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
Measured: 28 days
Baby's anthropometric measures_weight
Weight (kg) of the baby at baseline, 14 days and 28 days.
Measured: 28 days
Baby's anthropometric measures_height
Height (cm) of the baby at baseline, 14 days and 28 days.
Measured: 28 days
Baby's anthropometric measures_BMI
BMI (kg/m2) of the baby at baseline, 14 days and 28 days.
Measured: 28 days
Data about the intestinal health of the baby_stool frequency
Data about stool frequency (times per day)
Measured: 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)
Measured: 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)
Measured: 28 days
Data about sleep parameters of the baby
Hours of night sleeping per day and hours of total sleeping during the day
Measured: 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start30 Jan 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk ExpressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruth Blanco Rojo, PhD, Principal investigator, Biosearch S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639232
- Sponsor's protocol ID
- P047
- Status last verified
- Feb 2025
- First submitted
- 16 Oct 2020
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04639232
- Acronym / sponsor ID
- P047
- Conditions
- Breast Milk Expression
- Keywords
- Breastfeeding, Galactogogue, Plant extracts, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: PlaceboVolunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin. |
| Prob-milk | Experimental | Dietary Supplement: Prob-milkVolunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination. |
| Voluntas-Prob | Experimental | Dietary Supplement: Voluntas-ProbVolunteers will take 6 capsules per day for 28 days a capsule containing the combination of plant extracts and the inactivated probiotic strain |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboEach participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life. | Dietary supplement | Control group |
| Prob-milkEach 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 |
| Voluntas-ProbEach 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 |
Primary outcome
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
12 secondary outcomes
Nutritional composition of breast milk
Time frame: 28 days
Measurement of IL-8 in breast milk
Time frame: 28 days
Measurement of IgA in breast milk
Time frame: 28 days
Baby feces microbiota
Time frame: 28 days
Baby's anthropometric measures_weight
Time frame: 28 days
Baby's anthropometric measures_height
Time frame: 28 days
Baby's anthropometric measures_BMI
Time frame: 28 days
Data about the intestinal health of the baby_stool frequency
Time frame: 28 days
Data about the intestinal health of the baby_color of the faeces
Time frame: 28 days
Data about the intestinal health of the baby_consistency of the feces
Time frame: 28 days
Data about sleep parameters of the baby
Time frame: 28 days
Infantile colick symptoms
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Blanco Rojo, PhD principal investigator
Biosearch S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prob-milk and Voluntas-Prob in people with Breast Milk Expression, run by Biosearch S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of breast milk (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.