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Breastfeeding Study

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ClinicalTrials.gov Identifier: NCT03387124
Recruitment Status : Completed
First Posted : December 29, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date December 21, 2017
First Posted Date December 29, 2017
Last Update Posted Date April 24, 2019
Actual Study Start Date January 22, 2018
Actual Primary Completion Date October 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2017)
Stool Consistency Score [ Time Frame: 155 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03387124 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2017)
  • Fecal Microbiota Composition [ Time Frame: 155 days ]
  • Changes in Weight from baseline to 155 days [ Time Frame: 155 days ]
    weight (kg)
  • Changes in Length from baseline to 155 days [ Time Frame: 155 days ]
    length (cm)
  • Changes in Head Circumference from baseline to 155 days [ Time Frame: 155 days ]
    head circumference (cm)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breastfeeding Study
Official Title Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants
Brief Summary The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 75 healthy term exclusively breastfed infants
Condition Infant Term Birth
Intervention Other: Breastfed infants
Breastmilk
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2017)
75
Original Estimated Enrollment Same as current
Actual Study Completion Date December 11, 2018
Actual Primary Completion Date October 24, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 26 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT03387124
Other Study ID Numbers 16.23.INF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Nestlé
Study Sponsor Nestlé
Collaborators Not Provided
Investigators
Principal Investigator: Elvira M Estorninos, MD University of Alberta
PRS Account Nestlé
Verification Date April 2019