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Impact of B. Bifidum 900791 Intake on Breast Milk Characteristics of Obese Mothers

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ClinicalTrials.gov Identifier: NCT03913364
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Gotteland, University of Chile

Brief Summary:

Human breast milk harbours a specific microbiota including bacteria from the Lactobacillus and Bifidobacterium genera, that contribute to the bacterial colonization of the infant gut in the post-natal period. An entero-mammary pathway has been suggested by which selected bacteria from the maternal gut would be transmitted to the mammary gland through dendritic cell trafficking by the lymphatic pathway. Accordingly, some studies have detected the presence of probiotic strains in breast milk from mothers who were consuming them. The administration of probiotic supplements to lactating mothers has also been shown to modulate milk concentrations of inflammatory markers and metabolic hormones, impacting positively the infant health. Noteworthily, many of these inflammatory and hormonal biomarkers are altered in the breastmilk from pre-pregnancy obese mothers, compared with these who were normal-weight, possibly affecting the infant health. It is unclear whether the breast milk microbiota of obese mothers is altered and the impact of probiotic administration on the breastmilk microbiota and on the normalization of breastmilk alterations in obese mothers is unknown.

Based on these antecedents, the aim of this study is to determine if the administration of a B. bifidum 900791-containing foodstuff to mothers during the perinatal period normalizes the breast milk concentrations of interleukin (IL)-6, C-Reactive Protein (CRP), insulin, adiponectin and resistin, and the microbiota of obese mothers, compared with normal-weight mothers.


Condition or disease Intervention/treatment Phase
Maternal Obesity Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Obese mothers and normal-weight mothers will each be randomized in two groups to receive the probiotic product or the placebo. Colostrum and breastmilk samples will obtained at days 2 and 30 post-partum, respectively, and infant fecal samples at day 30.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of B. Bifidum 900791 as a Modulator of Microbiota, Inflammatory Mediators and Metabolic Hormones in Breast Milk From Obese Mothers
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Experimental Obese mothers
One portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (>10(exp7)/g) every other day during the last month of gestation and the first month of lactation
Dietary Supplement: Probiotic
B. bifidum 900791-containing ice cream
Other Name: Bifidice

Placebo Comparator: Placebo Obese mothers
One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
Dietary Supplement: Placebo
Placebo ice-cream

Experimental: Experimental normal weight mothers
One portion (50g) of an ice-cream containing B. bifidum 900791 (>10(exp7)/g) every other day during the last month of gestation and the first month of lactation
Dietary Supplement: Probiotic
B. bifidum 900791-containing ice cream
Other Name: Bifidice

Placebo Comparator: Placebo normal weight mothers
One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
Dietary Supplement: Placebo
Placebo ice-cream




Primary Outcome Measures :
  1. C-Reactive Protein concentration in breastmilk [ Time Frame: Day-30 ]
    Concentration of CRP in breastmilk


Secondary Outcome Measures :
  1. IL-6 concentration in breastmilk [ Time Frame: Day 30 ]
    Concentration of IL-6 in breastmilk

  2. Insulin concentration in breastmilk [ Time Frame: Day 30 ]
    Concentration of Insulin in breastmilk

  3. Resistin concentration in breastmilk [ Time Frame: Day 30 ]
    Concentration of resistin in breastmilk

  4. Adiponectin concentration in breastmilk [ Time Frame: Day 30 ]
    Concentration of adiponectin in breastmilk

  5. Milk microbiota diversity [ Time Frame: Day 30 ]
    Intra-and Interindividual diversity of the milk microbiota

  6. Milk microbiota composition [ Time Frame: Day 30 ]
    Relative abundancies of the different bacterial taxa detected by high throughput sequencing

  7. Presence of B. bifidum 900791 in breastmilk [ Time Frame: Day 30 ]
    Presence of the probiotic strain B. bifidum 900791 in breastmilk

  8. Infant fecal microbiota diversity [ Time Frame: Day 30 ]
    Intra-and Interindividual diversity of the infant fecal microbiota

  9. Infant fecal microbiota composition [ Time Frame: Day 30 ]
    Relative abundancies of the different bacterial taxa detected by high throughput sequencing


Other Outcome Measures:
  1. Colostrum IL-6 [ Time Frame: Day 2 ]
    Concentrations of IL-6 in colostrum

  2. Colostrum CRP [ Time Frame: Day 2 ]
    Concentrations of CRP in colostrum

  3. Colostrum insulin [ Time Frame: Day 2 ]
    Concentrations of insulin in colostrum

  4. Colostrum resistin [ Time Frame: Day 2 ]
    Concentrations of resistin in colostrum

  5. Colostrum adiponectin [ Time Frame: Day 2 ]
    Concentrations of adiponectin in colostrum

  6. Colostrum microbiota diversity [ Time Frame: Day 2 ]
    Intra-and Interindividual diversity of colostrum

  7. Presence of the probiotic strain in colostrum [ Time Frame: Day 2 ]
    Presence of the probiotic strain B. bifidum 900791 in colostrum

  8. Colostrum microbiota composition [ Time Frame: Day 2 ]
    Relative abundancies of the different bacterial taxa detected by high throughput sequencing

  9. Presence of mastitis [ Time Frame: Days 0-30 pp. ]
    Presence of mastitis in the mother during the first month post-partum

  10. Presence of infant colic [ Time Frame: Days 0-30 pp. ]
    Appearance of colic in the infant during the first month post-partum



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women in their last month of pregnancy, who were normal-weight (18.5<BMI<25kg/m2) or who were obese (BMI>30kg/m2) before pregnancy, and their children

Women recruited should have expressed their wish to have their child through normal delivery, and to breastfeed at least during the first month post-partum.

Exclusion Criteria:

  • Women with chronic diseases (type 2 diabetes, renal diseases, autoimmune diseases, tumor, chronic inflammatory diseases, etc.).
  • Women with a history of digestive surgery.
  • Women whose children are hospitalized more than 24hours in the neonatal unit
  • Women who require antibiotic treatment during the perinatal period.

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): NCT03913364


Contacts
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Contact: Martin Gotteland, PhD 56-2-29786977 mgottela@med.uchile.cl
Contact: Carvajal Bielka, RM, MaSc 56-2-29786611 bielka.carvajal@gmail.com

Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Cynthia Barrera, PhD Univ. of Chile
Principal Investigator: Fabien Magne, PhD University of Chile

Publications of Results:

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Responsible Party: Martin Gotteland, Head, Lab. of Digestive physiology, University of Chile
ClinicalTrials.gov Identifier: NCT03913364     History of Changes
Other Study ID Numbers: UChile-Bifidice-1
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
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 Martin Gotteland, University of Chile:
obesity
breast milk
probiotic
IL-6
CRP
Insulin
Adiponectin
Resistin
breastmilk microbiota
Bifidobacterium
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms