Back to resultsEffect 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
Primary Purpose
Breast Milk Expression
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Placebo
Prob-milk
Voluntas-Prob
Sponsored by
About this trial
This is an interventional other trial for Breast Milk Expression focused on measuring Breastfeeding, Galactogogue, Plant extracts, Probiotics
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Centro de Salud de Maracena
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control group
Prob-milk
Voluntas-Prob
Arm Description
Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin.
Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination.
Volunteers will take 6 capsules per day for 28 days a capsule containing the combination of plant extracts and the inactivated probiotic strain
Outcomes
Primary Outcome Measures
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.
Microbiota of breast milk
Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk
Secondary Outcome Measures
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
Measurement of IL-8 in breast milk
Analysis of the concentration of IL-8 (pg/mL) in breast milk
Measurement of IgA in breast milk
Analysis of the concentration of IgA (ug/mL) in breast milk
Baby feces microbiota
Presence of Lactobacillus spp, Bifidobacterium spp., Streptococcus spp. Staphylococcus spp, Bacteroides spp, E. coli spp, Clostridium spp in baby faeces
Baby's anthropometric measures_weight
Weight (kg) of the baby at baseline, 14 days and 28 days.
Baby's anthropometric measures_height
Height (cm) of the baby at baseline, 14 days and 28 days.
Baby's anthropometric measures_BMI
BMI (kg/m2) of the baby at baseline, 14 days and 28 days.
Data about the intestinal health of the baby_stool frequency
Data about stool frequency (times per day)
Data about the intestinal health of the baby_color of the faeces
Data about color of the feces (yellow, mustard, brown, grey, or green)
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)
Data about sleep parameters of the baby
Hours of night sleeping per day and hours of total sleeping during the day
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04639232
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2021 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Milk Expression
Keywords
Breastfeeding, Galactogogue, Plant extracts, Probiotics
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Volunteers will take 6 capsules per day for 28 days a capsule containing maltodextrin.
Arm Title
Prob-milk
Arm Type
Experimental
Arm Description
Volunteers will take 6 capsules per day for 28 days a capsule containing the probiotics combination.
Arm Title
Voluntas-Prob
Arm Type
Experimental
Arm Description
Volunteers will take 6 capsules per day for 28 days a capsule containing the combination of plant extracts and the inactivated probiotic strain
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
Intervention Type
Dietary Supplement
Intervention Name(s)
Prob-milk
Intervention Description
Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
Intervention Type
Dietary Supplement
Intervention Name(s)
Voluntas-Prob
Intervention Description
Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
Primary Outcome Measure Information:
Title
Volume of breast milk
Description
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.
Time Frame
28 days
Title
Microbiota of breast milk
Description
Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Nutritional composition of breast milk
Description
Analysis of the content of proteins, fatty acids profile and total fat content, and iron and calcium content in breast milk
Time Frame
28 days
Title
Measurement of IL-8 in breast milk
Description
Analysis of the concentration of IL-8 (pg/mL) in breast milk
Time Frame
28 days
Title
Measurement of IgA in breast milk
Description
Analysis of the concentration of IgA (ug/mL) in breast milk
Time Frame
28 days
Title
Baby feces microbiota
Description
Presence of Lactobacillus spp, Bifidobacterium spp., Streptococcus spp. Staphylococcus spp, Bacteroides spp, E. coli spp, Clostridium spp in baby faeces
Time Frame
28 days
Title
Baby's anthropometric measures_weight
Description
Weight (kg) of the baby at baseline, 14 days and 28 days.
Time Frame
28 days
Title
Baby's anthropometric measures_height
Description
Height (cm) of the baby at baseline, 14 days and 28 days.
Time Frame
28 days
Title
Baby's anthropometric measures_BMI
Description
BMI (kg/m2) of the baby at baseline, 14 days and 28 days.
Time Frame
28 days
Title
Data about the intestinal health of the baby_stool frequency
Description
Data about stool frequency (times per day)
Time Frame
28 days
Title
Data about the intestinal health of the baby_color of the faeces
Description
Data about color of the feces (yellow, mustard, brown, grey, or green)
Time Frame
28 days
Title
Data about the intestinal health of the baby_consistency of the feces
Description
Data about consistency of the feces (hard lumps, sausage with cracks, soft sausage, mushy (like porridge),or watery)
Time Frame
28 days
Title
Data about sleep parameters of the baby
Description
Hours of night sleeping per day and hours of total sleeping during the day
Time Frame
28 days
Title
Infantile colick symptoms
Description
Presence of infantile colick defined as vigorous and inconsolable crying for more than 3 hours a day for at least 3 weeks
Time Frame
28 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breastfeeding mothers
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Blanco Rojo, PhD
Phone
+34913802973
Email
rblanco@biosearchlife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Blanco Rojo, PhD
Organizational Affiliation
Biosearch S.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud de Maracena
City
Maracena
State/Province
Granada
ZIP/Postal Code
18200
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Blanco Rojo
First Name & Middle Initial & Last Name & Degree
Mª Vega Almazán Fernández de Bobadilla, M.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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