NCT04639232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

October 16, 2020

Last Update Submit

February 4, 2025

Conditions

Breast Milk Expression

Keywords

BreastfeedingGalactogoguePlant extractsProbiotics

Outcome Measures

Primary Outcomes (2)

  • 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.

    28 days

  • Microbiota of breast milk

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

    28 days

Secondary Outcomes (12)

  • Nutritional composition of breast milk

    28 days

  • Measurement of IL-8 in breast milk

    28 days

  • Measurement of IgA in breast milk

    28 days

  • Baby feces microbiota

    28 days

  • Baby's anthropometric measures_weight

    28 days

  • +7 more secondary outcomes

Study Arms (3)

Control group

PLACEBO COMPARATOR

Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin.

Dietary Supplement: Placebo

Prob-milk

EXPERIMENTAL

Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination.

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

Dietary Supplement: Voluntas-Prob

Interventions

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.

Control group
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.

Prob-milk
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.

Voluntas-Prob

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreastfeeding mothers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Salud de Maracena

Maracena, Granada, 18200, Spain

Location

MeSH Terms

Conditions

Breast Milk ExpressionBreast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Ruth Blanco Rojo, PhD

    Biosearch S.A.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2020

First Posted

November 20, 2020

Study Start

January 30, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)