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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03913364
Enrollment
48
Registered
2019-04-12
Start date
2019-06-01
Completion date
2019-12-31
Last updated
2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Obesity

Keywords

obesity, breast milk, probiotic, IL-6, CRP, Insulin, Adiponectin, Resistin, breastmilk microbiota, Bifidobacterium

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.

Interventions

DIETARY_SUPPLEMENTProbiotic

B. bifidum 900791-containing ice cream

DIETARY_SUPPLEMENTPlacebo

Placebo ice-cream

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

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.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 30 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
C-Reactive Protein concentration in breastmilkDay-30Concentration of CRP in breastmilk

Secondary

MeasureTime frameDescription
IL-6 concentration in breastmilkDay 30Concentration of IL-6 in breastmilk
Insulin concentration in breastmilkDay 30Concentration of Insulin in breastmilk
Resistin concentration in breastmilkDay 30Concentration of resistin in breastmilk
Adiponectin concentration in breastmilkDay 30Concentration of adiponectin in breastmilk
Milk microbiota diversityDay 30Intra-and Interindividual diversity of the milk microbiota
Milk microbiota compositionDay 30Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Presence of B. bifidum 900791 in breastmilkDay 30Presence of the probiotic strain B. bifidum 900791 in breastmilk
Infant fecal microbiota diversityDay 30Intra-and Interindividual diversity of the infant fecal microbiota
Infant fecal microbiota compositionDay 30Relative abundancies of the different bacterial taxa detected by high throughput sequencing

Other

MeasureTime frameDescription
Colostrum IL-6Day 2Concentrations of IL-6 in colostrum
Colostrum CRPDay 2Concentrations of CRP in colostrum
Colostrum insulinDay 2Concentrations of insulin in colostrum
Colostrum resistinDay 2Concentrations of resistin in colostrum
Colostrum adiponectinDay 2Concentrations of adiponectin in colostrum
Colostrum microbiota diversityDay 2Intra-and Interindividual diversity of colostrum
Presence of the probiotic strain in colostrumDay 2Presence of the probiotic strain B. bifidum 900791 in colostrum
Colostrum microbiota compositionDay 2Relative abundancies of the different bacterial taxa detected by high throughput sequencing
Presence of mastitisDays 0-30 pp.Presence of mastitis in the mother during the first month post-partum
Presence of infant colicDays 0-30 pp.Appearance of colic in the infant during the first month post-partum

Contacts

Primary ContactMartin Gotteland, PhD
mgottela@med.uchile.cl56-2-29786977
Backup ContactCarvajal Bielka, RM, MaSc
bielka.carvajal@gmail.com56-2-29786611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026