Clinical trial NCT02301728: Study on Short Chain Fatty Acids Concentration in Breast Milk and Its Correlation With the Maternal Diet
Official title: Short Chain Fatty Acids in Breast Milk
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Short Chain Fatty Acids Concentration in Breast Milk
Keywords: breast milk
short chain fatty acids
maternal diet
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.

Brief summary: The purpose of this study is to determine whether the acetate, butyrate and propionate concentration in breast milk and to evaluate the possible correlation of these concentrations with maternal diet.


Eligibility criteria: Inclusion Criteria:

* parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.

Exclusion Criteria:

* infections,
* diabetes and other chronic diseases at the level of each organ or system,
* diseases of pregnancy.
* antibiotics, prebiotics, probiotics and synbiotics in the 30 days prior to the first observation.

Primary outcomes:
measure: butyrate, acetate and propionate concentration
timeFrame: 10 days after delivery and every 30 days until the fifth month after delivery
Secondary outcomes:
measure: Relationship between short chain fatty acids in breast milk and maternal diet (amount of fibers in maternal diet and based on this it will evaluate the variations in short chain fatty acids concentration)
timeFrame: 10 days after delivery and every 30 days until the fifth month after delivery
Other outcomes:
Locations:
city: Naples
country: Italy
facility: "Federico II" University of Naples
Study officials:
affiliation: "Federico II" University of Naples
name: Annalisa Passariello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Belderbos ME, Houben ML, van Bleek GM, Schuijff L, van Uden NO, Bloemen-Carlier EM, Kimpen JL, Eijkemans MJ, Rovers M, Bont LJ. Breastfeeding modulates neonatal innate immune responses: a prospective birth cohort study. Pediatr Allergy Immunol. 2012 Feb;23(1):65-74. doi: 10.1111/j.1399-3038.2011.01230.x. Epub 2011 Nov 22.