Clinical trial NCT03913364: Impact of B. Bifidum 900791 Intake on Breast Milk Characteristics of Obese Mothers
Official title: Evaluation of B. Bifidum 900791 as a Modulator of Microbiota, Inflammatory Mediators and Metabolic Hormones in Breast Milk From Obese Mothers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal Obesity
Keywords: obesity
breast milk
probiotic
IL-6
CRP
Insulin
Adiponectin
Resistin
breastmilk microbiota
Bifidobacterium
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 48
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: C-Reactive Protein concentration in breastmilk
timeFrame: Day-30
Secondary outcomes:
measure: IL-6 concentration in breastmilk
timeFrame: Day 30
measure: Insulin concentration in breastmilk
timeFrame: Day 30
measure: Resistin concentration in breastmilk
timeFrame: Day 30
measure: Adiponectin concentration in breastmilk
timeFrame: Day 30
measure: Milk microbiota diversity
timeFrame: Day 30
measure: Milk microbiota composition
timeFrame: Day 30
measure: Presence of B. bifidum 900791 in breastmilk
timeFrame: Day 30
measure: Infant fecal microbiota diversity
timeFrame: Day 30
measure: Infant fecal microbiota composition
timeFrame: Day 30
Other outcomes:
measure: Colostrum IL-6
timeFrame: Day 2
measure: Colostrum CRP
timeFrame: Day 2
measure: Colostrum insulin
timeFrame: Day 2
measure: Colostrum resistin
timeFrame: Day 2
measure: Colostrum adiponectin
timeFrame: Day 2
measure: Colostrum microbiota diversity
timeFrame: Day 2
measure: Presence of the probiotic strain in colostrum
timeFrame: Day 2
measure: Colostrum microbiota composition
timeFrame: Day 2
measure: Presence of mastitis
timeFrame: Days 0-30 pp.
measure: Presence of infant colic
timeFrame: Days 0-30 pp.
Locations:
Study officials:
affiliation: Univ. of Chile
name: Cynthia Barrera, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Fabien Magne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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