Evaluation of B. Bifidum 900791 as a Modulator of Microbiota, Inflammatory Mediators and Metabolic Hormones in Breast Milk From Obese Mothers
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 48
- Primary Endpoint
- C-Reactive Protein concentration in breastmilk
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 30 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •* Women in their last month of pregnancy, who were normal-weight (18.5\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.
Arms & Interventions
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
Intervention: Placebo (Dietary Supplement)
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
Intervention: Probiotic (Dietary Supplement)
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
Intervention: Placebo (Dietary Supplement)
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
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
C-Reactive Protein concentration in breastmilk
Time Frame: Day-30
Concentration of CRP in breastmilk
Secondary Outcomes
- IL-6 concentration in breastmilk(Day 30)
- Resistin concentration in breastmilk(Day 30)
- Insulin concentration in breastmilk(Day 30)
- Adiponectin concentration in breastmilk(Day 30)
- Milk microbiota diversity(Day 30)
- Presence of B. bifidum 900791 in breastmilk(Day 30)
- Infant fecal microbiota composition(Day 30)
- Milk microbiota composition(Day 30)
- Infant fecal microbiota diversity(Day 30)
Investigators
Martin Gotteland
Head, Lab. of Digestive physiology
University of Chile
