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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

NCT04639232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

  • Breast Milk Expression

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.

Sponsors & Collaborators

  • Biosearch S.A.

    lead INDUSTRY

Principal Investigators

  • Ruth Blanco Rojo, PhD · Biosearch S.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-30
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639232 on ClinicalTrials.gov