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Breastfeeding Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03387124
Recruitment Status : Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.

Condition or disease Intervention/treatment
Infant Term Birth Other: Breastfed infants

Detailed Description:
This is a prospective, observational, non-interventional study. The purpose of this study is to evaluate the stool consistency and variability in fecal microbiota composition, diversity, and abundance of defined taxa in 75 healthy, term, exclusively breastfed infants. All enrolled infants will participate in the trial for approximately 169 days.

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Breastfed infants
    Breastmilk


Primary Outcome Measures :
  1. Stool Consistency Score [ Time Frame: 155 days ]

Secondary Outcome Measures :
  1. Fecal Microbiota Composition [ Time Frame: 155 days ]
  2. Changes in Weight from baseline to 155 days [ Time Frame: 155 days ]
    weight (kg)

  3. Changes in Length from baseline to 155 days [ Time Frame: 155 days ]
    length (cm)

  4. Changes in Head Circumference from baseline to 155 days [ Time Frame: 155 days ]
    head circumference (cm)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 26 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
75 healthy term exclusively breastfed infants
Criteria

Inclusion Criteria:

  • Written informed consent
  • Infants whose parent(s)/LAR who have reached the legal age of majority in the Philippines
  • Infants whose parent(s)/LAR are willing and able to comply with study requirements
  • Infants whose parent(s)/LAR who are able to be contacted directly by telephone throughout the study
  • Healthy term, singleton infant at birth
  • Between 21 to 26 days post-natal age at enrollment visit
  • Weight-for-length and head circumference-for-age z-scores are ≥ -3 and ≤ +3 according to WHO Child Growth Standards
  • Infants of parent(s)/LAR who have previously made the decision to breastfeed their infant at the time of enrollment

Exclusion Criteria:

  • Infants with conditions requiring infant feedings other than those specified in the protocol
  • Infants receiving weaning foods or liquids
  • Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
  • Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
  • Infants or infants whose parent(s)/LAR who cannot be expected to comply with the protocol or with study procedures

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): NCT03387124


Locations
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Philippines
Asian Hospital and Medical Center
Muntinlupa, Alabang, Philippines, 1780
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Elvira M Estorninos, MD University of Alberta

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03387124     History of Changes
Other Study ID Numbers: 16.23.INF
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No