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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Milk Expression
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Prob-milk; Dietary supplement: Voluntas-Prob

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruth Blanco Rojo, PhD; Phone Number: +34913802973; Email: rblanco@biosearchlife.com

Study Locations

• Spain
  • Granada
    • Maracena, Granada, Spain, 18200
      • Centro de Salud de Maracena
      • Contact: Ruth Blanco Rojo
      • Principal Investigator: Mª Vega Almazán Fernández de Bobadilla, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Lactating women between 18 and 45 years old, who have given birth to a healthy baby at term (born between 37 and 42 weeks).
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:

1. Suffering from any disease that may hinder or prevent breastfeeding
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin.	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.
Experimental: Prob-milk; Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination.	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.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days
Measurement of IL-8 in breast milk	Analysis of the concentration of IL-8 (pg/mL) in breast milk	28 days
Measurement of IgA in breast milk	Analysis of the concentration of IgA (ug/mL) in breast milk	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	28 days
Baby's anthropometric measures_weight	Weight (kg) of the baby at baseline, 14 days and 28 days.	28 days
Baby's anthropometric measures_height	Height (cm) of the baby at baseline, 14 days and 28 days.	28 days
Baby's anthropometric measures_BMI	BMI (kg/m2) of the baby at baseline, 14 days and 28 days.	28 days
Data about the intestinal health of the baby_stool frequency	Data about stool frequency (times per day)	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)	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)	28 days
Data about sleep parameters of the baby	Hours of night sleeping per day and hours of total sleeping during the day	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	28 days

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Principal Investigator: Ruth Blanco Rojo, PhD, Biosearch S.A.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 30, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Probiotics; Breastfeeding; Plant extracts; Galactogogue
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains; Antirheumatic Agents; Gout Suppressants; Renal Agents; Uricosuric Agents; Probenecid
• Other Study ID Numbers: P047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No