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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of B. Bifidum 900791 as a Modulator of Microbiota, Inflammatory Mediators and Metabolic Hormones in Breast Milk From Obese Mothers

Conditions
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Maternal Obesity

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Obese mothers<br>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<br>* B. bifidum 900791-containing ice cream<br>* Other names: Bifidice;|
| Placebo Comparator: Placebo Obese mothers<br>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<br>* Placebo ice-cream<br>|
| Experimental: Experimental normal weight mothers<br>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<br>* B. bifidum 900791-containing ice cream<br>* Other names: Bifidice;|
| Placebo Comparator: Placebo normal weight mothers<br>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<br>* Placebo ice-cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive Protein concentration in breastmilk | Concentration of CRP in breastmilk | Day-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 concentration in breastmilk | Concentration of IL-6 in breastmilk | Day 30 | 
| Insulin concentration in breastmilk | Concentration of Insulin in breastmilk | Day 30 | 
| Resistin concentration in breastmilk | Concentration of resistin in breastmilk | Day 30 | 
| Adiponectin concentration in breastmilk | Concentration of adiponectin in breastmilk | Day 30 | 
| Milk microbiota diversity | Intra-and Interindividual diversity of the milk microbiota | Day 30 | 
| Milk microbiota composition | Relative abundancies of the different bacterial taxa detected by high throughput sequencing | Day 30 | 
| Presence of B. bifidum 900791 in breastmilk | Presence of the probiotic strain B. bifidum 900791 in breastmilk | Day 30 | 
| Infant fecal microbiota diversity | Intra-and Interindividual diversity of the infant fecal microbiota | Day 30 | 
| Infant fecal microbiota composition | Relative abundancies of the different bacterial taxa detected by high throughput sequencing | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRP, obesity, breast milk, probiotic, IL-6, Insulin, Adiponectin, Resistin, breastmilk microbiota, Bifidobacterium