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

University of Chile

Status: Unknown

Conditions: Maternal Obesity

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03913364

UChile-Bifidice-1

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

Experimental Obese mothers

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo Obese mothers

Placebo Comparator group

Description:

One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation

Treatment:

Dietary Supplement: Placebo

Experimental normal weight mothers

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo normal weight mothers

Placebo Comparator group

Description:

One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation

Treatment:

Dietary Supplement: Placebo