Impact of B. Bifidum 900791 Intake on Breast Milk Characteristics of Obese Mothers
- Conditions
- Maternal Obesity
- Interventions
- Dietary Supplement: ProbioticDietary Supplement: Placebo
- Registration Number
- NCT03913364
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental normal weight mothers Probiotic 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 Placebo normal weight mothers Placebo One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation Experimental Obese mothers Probiotic 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 Placebo Obese mothers Placebo One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
- Primary Outcome Measures
Name Time Method C-Reactive Protein concentration in breastmilk Day-30 Concentration of CRP in breastmilk
- Secondary Outcome Measures
Name Time Method IL-6 concentration in breastmilk Day 30 Concentration of IL-6 in breastmilk
Resistin concentration in breastmilk Day 30 Concentration of resistin in breastmilk
Insulin concentration in breastmilk Day 30 Concentration of Insulin in breastmilk
Adiponectin concentration in breastmilk Day 30 Concentration of adiponectin in breastmilk
Milk microbiota diversity Day 30 Intra-and Interindividual diversity of the milk microbiota
Presence of B. bifidum 900791 in breastmilk Day 30 Presence of the probiotic strain B. bifidum 900791 in breastmilk
Infant fecal microbiota composition Day 30 Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Milk microbiota composition Day 30 Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Infant fecal microbiota diversity Day 30 Intra-and Interindividual diversity of the infant fecal microbiota