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

Breast Milk Expression Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04639232
• Other study ID #: P047
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Biosearch S.A.
• Contact: Ruth Blanco Rojo, PhD
• Phone: +34913802973
• Email: rblanco[@]biosearchlife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk Expression
• Sprains and Strains

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Centro de Salud de Maracena	Maracena	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

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