Clinical Trials Directory

Trials / Unknown

UnknownNCT03913364

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
Phase
N/A
Study type
Interventional
Enrollment
48 (estimated)
Sponsor
University of Chile · Academic / Other
Sex
Female
Age
20 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTProbioticB. bifidum 900791-containing ice cream
DIETARY_SUPPLEMENTPlaceboPlacebo ice-cream

Timeline

Start date
2019-06-01
Primary completion
2019-08-30
Completion
2019-12-31
First posted
2019-04-12
Last updated
2019-05-30

Source: ClinicalTrials.gov record NCT03913364. Inclusion in this directory is not an endorsement.