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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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ClinicalTrials.gov Identifier: NCT04639232
Recruitment Status : Not yet recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Milk Expression Dietary Supplement: Placebo Dietary Supplement: Prob-milk Dietary Supplement: Voluntas-Prob Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Estimated Study Start Date : January 30, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Volume of breast milk [ Time Frame: 28 days ]
    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.

  2. Microbiota of breast milk [ Time Frame: 28 days ]
    Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk


Secondary Outcome Measures :
  1. Nutritional composition of breast milk [ Time Frame: 28 days ]
    Analysis of the content of proteins, fatty acids profile and total fat content, and iron and calcium content in breast milk

  2. Measurement of IL-8 in breast milk [ Time Frame: 28 days ]
    Analysis of the concentration of IL-8 (pg/mL) in breast milk

  3. Measurement of IgA in breast milk [ Time Frame: 28 days ]
    Analysis of the concentration of IgA (ug/mL) in breast milk

  4. Baby feces microbiota [ Time Frame: 28 days ]
    Presence of Lactobacillus spp, Bifidobacterium spp., Streptococcus spp. Staphylococcus spp, Bacteroides spp, E. coli spp, Clostridium spp in baby faeces

  5. Baby's anthropometric measures_weight [ Time Frame: 28 days ]
    Weight (kg) of the baby at baseline, 14 days and 28 days.

  6. Baby's anthropometric measures_height [ Time Frame: 28 days ]
    Height (cm) of the baby at baseline, 14 days and 28 days.

  7. Baby's anthropometric measures_BMI [ Time Frame: 28 days ]
    BMI (kg/m2) of the baby at baseline, 14 days and 28 days.

  8. Data about the intestinal health of the baby_stool frequency [ Time Frame: 28 days ]
    Data about stool frequency (times per day)

  9. Data about the intestinal health of the baby_color of the faeces [ Time Frame: 28 days ]
    Data about color of the feces (yellow, mustard, brown, grey, or green)

  10. Data about the intestinal health of the baby_consistency of the feces [ Time Frame: 28 days ]
    Data about consistency of the feces (hard lumps, sausage with cracks, soft sausage, mushy (like porridge),or watery)

  11. Data about sleep parameters of the baby [ Time Frame: 28 days ]
    Hours of night sleeping per day and hours of total sleeping during the day

  12. Infantile colick symptoms [ Time Frame: 28 days ]
    Presence of infantile colick defined as vigorous and inconsolable crying for more than 3 hours a day for at least 3 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breastfeeding mothers
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639232


Contacts
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Contact: Ruth Blanco Rojo, PhD +34913802973 rblanco@biosearchlife.com

Locations
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Spain
Centro de Salud de Maracena
Maracena, Granada, Spain, 18200
Contact: Ruth Blanco Rojo         
Principal Investigator: Mª Vega Almazán Fernández de Bobadilla, M.D         
Sponsors and Collaborators
Biosearch S.A.
Investigators
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Principal Investigator: Ruth Blanco Rojo, PhD Biosearch S.A.
More Information
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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT04639232    
Other Study ID Numbers: P047
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biosearch S.A.:
Breastfeeding
Galactogogue
Plant extracts
Probiotics
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries
Probenecid
Uricosuric Agents
 Gout Suppressants
Antirheumatic Agents
Renal Agents