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

Sponsor

University of Chile (Other)

Overall Status

Unknown status

CT.gov ID

NCT03913364

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Obesity	Dietary Supplement: Probiotic Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Aug 30, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Dietary Supplement: Probiotic B. bifidum 900791-containing ice cream Other Names: Bifidice
Placebo Comparator: 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	Dietary Supplement: Placebo Placebo ice-cream
Experimental: 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	Dietary Supplement: Probiotic B. bifidum 900791-containing ice cream Other Names: Bifidice
Placebo Comparator: 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	Dietary Supplement: Placebo Placebo ice-cream

Outcome Measures

Primary Outcome Measures

C-Reactive Protein concentration in breastmilk [Day-30]
Concentration of CRP in breastmilk

Secondary Outcome Measures

IL-6 concentration in breastmilk [Day 30]
Concentration of IL-6 in breastmilk
Insulin concentration in breastmilk [Day 30]
Concentration of Insulin in breastmilk
Resistin concentration in breastmilk [Day 30]
Concentration of resistin 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
Milk microbiota composition [Day 30]
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Presence of B. bifidum 900791 in breastmilk [Day 30]
Presence of the probiotic strain B. bifidum 900791 in breastmilk
Infant fecal microbiota diversity [Day 30]
Intra-and Interindividual diversity of the infant fecal microbiota
Infant fecal microbiota composition [Day 30]
Relative abundancies of the different bacterial taxa detected by high throughput sequencing

Other Outcome Measures

Colostrum IL-6 [Day 2]
Concentrations of IL-6 in colostrum
Colostrum CRP [Day 2]
Concentrations of CRP in colostrum
Colostrum insulin [Day 2]
Concentrations of insulin in colostrum
Colostrum resistin [Day 2]
Concentrations of resistin in colostrum
Colostrum adiponectin [Day 2]
Concentrations of adiponectin in colostrum
Colostrum microbiota diversity [Day 2]
Intra-and Interindividual diversity of colostrum
Presence of the probiotic strain in colostrum [Day 2]
Presence of the probiotic strain B. bifidum 900791 in colostrum
Colostrum microbiota composition [Day 2]
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Presence of mastitis [Days 0-30 pp.]
Presence of mastitis in the mother during the first month post-partum
Presence of infant colic [Days 0-30 pp.]
Appearance of colic in the infant during the first month post-partum

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.