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Study on Short Chain Fatty Acids Concentration in Breast Milk and Its Correlation With the Maternal Diet

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ClinicalTrials.gov Identifier: NCT02301728
Recruitment Status : Unknown
Verified November 2014 by Annalisa Passariello, Federico II University.
Recruitment status was:  Not yet recruiting
First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Annalisa Passariello, Federico II University

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.

Condition or disease Intervention/treatment
Short Chain Fatty Acids Concentration in Breast Milk Other: sampling of breast milk, obtaining information about the maternal diet

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Short Chain Fatty Acids in Breast Milk
Study Start Date : December 2014
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : May 2015

Intervention Details:
  • Other: sampling of breast milk, obtaining information about the maternal diet
    take samples of 3 ml breast milk and 3-days diet diaries


Primary Outcome Measures :
  1. butyrate, acetate and propionate concentration [ Time Frame: 10 days after delivery and every 30 days until the fifth month after delivery ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: 10 days after delivery and every 30 days until the fifth month after delivery ]
    Relationship between short chain fatty acids in breast milk and maternal diet will be measured by assessing the amount of fibers in maternal diet and based on this it will evaluate the variations in short chain fatty acids concentration. These assessments will be carried out by using a food diary carefully compiled by mothers before each sampling of breast milk



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301728


Contacts
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Contact: Annalisa Passariello, MD, PhD + 39 081 746 2680 annalisa.passariello@unina.it
Contact: roberto berni canani, MD, PhD + 39 081 746 2680 berni@unina.it

Locations
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Italy
"Federico II" University of Naples Recruiting
Naples, Italy, 80131
Contact: Annalisa Passariello, MD, PhD    + 39 081 746 2680    annalisa.passariello@unina.it   
Contact: roberto berni canani, MD, PhD    + 39 081 746 2680    berni@unina.it   
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Annalisa Passariello, MD, PhD "Federico II" University of Naples

Publications:

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Responsible Party: Annalisa Passariello, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT02301728     History of Changes
Other Study ID Numbers: BMB-100
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Annalisa Passariello, Federico II University:
breast milk
short chain fatty acids
maternal diet