NCT03913364

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

Status unknown NA Last updated 30 May 2019

What this trial tests

NA trial testing Probiotic in Maternal Obesity in 48 participants. Status unknown.

Timeline

1 June 2019

Primary endpoint
30 August 2019

31 December 2019

Quick facts

Lead sponsor	University of Chile
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	48
Start date	1 June 2019
Primary completion	30 August 2019
Estimated completion	31 December 2019

Drugs / interventions tested

• Probiotic
• Placebo

Conditions studied

• Maternal Obesity — all drugs for Maternal Obesity →

Sponsor

University of Chile

Who can join

Adults 20 to 30, female only, with Maternal Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.