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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-30
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2020-11-20
• Last updated: 2025-02-06

Locations

1 site across 1 country: Spain