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Clinical Trials/NCT03913364
NCT03913364UnknownNot Applicable

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

University of Chile0 sites48 target enrollmentStarted: June 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
48
Primary Endpoint
C-Reactive Protein concentration in breastmilk

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
20 Years to 30 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • * Women in their last month of pregnancy, who were normal-weight (18.5\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.

Arms & Interventions

Placebo normal weight mothers

Placebo Comparator

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

Intervention: Placebo (Dietary Supplement)

Experimental Obese mothers

Experimental

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

Intervention: Probiotic (Dietary Supplement)

Placebo Obese mothers

Placebo Comparator

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

Intervention: Placebo (Dietary Supplement)

Experimental normal weight mothers

Experimental

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

Intervention: Probiotic (Dietary Supplement)

Outcomes

Primary Outcomes

C-Reactive Protein concentration in breastmilk

Time Frame: Day-30

Concentration of CRP in breastmilk

Secondary Outcomes

  • IL-6 concentration in breastmilk(Day 30)
  • Resistin concentration in breastmilk(Day 30)
  • Insulin concentration in breastmilk(Day 30)
  • Adiponectin concentration in breastmilk(Day 30)
  • Milk microbiota diversity(Day 30)
  • Presence of B. bifidum 900791 in breastmilk(Day 30)
  • Infant fecal microbiota composition(Day 30)
  • Milk microbiota composition(Day 30)
  • Infant fecal microbiota diversity(Day 30)

Investigators

Sponsor
University of Chile
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martin Gotteland

Head, Lab. of Digestive physiology

University of Chile

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