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
NCT ID: NCT04639232
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2021-01-30
2022-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Control group
Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin.
Placebo
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
Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination.
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.
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
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.
Interventions
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Placebo
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
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
Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Biosearch S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Ruth Blanco Rojo, PhD
Role: PRINCIPAL_INVESTIGATOR
Biosearch S.A.
Locations
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Centro de Salud de Maracena
Maracena, Granada, Spain
Countries
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Other Identifiers
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P047
Identifier Type: -
Identifier Source: org_study_id
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