Breastfeeding Study

NCT03387124 | Completed

• 1 other identifier: 16.23.INF
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infant Term Birth

Outcome Measures

Primary Outcomes (1)

• Stool Consistency Score

  155 days

Secondary Outcomes (4)

• Fecal Microbiota Composition

  155 days

• Changes in Weight from baseline to 155 days

  155 days

• Changes in Length from baseline to 155 days

  155 days

• Changes in Head Circumference from baseline to 155 days

  155 days

Interventions

Breastfed infants OTHER

Breastmilk

Eligibility Criteria

• Age: 21 Days - 26 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

75 healthy term exclusively breastfed infants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Asian Hospital and Medical Center

City of Muntinlupa, Alabang, 1780, Philippines

Location

Related Publications (1)

• Samuel TM, Hartweg M, Lebumfacil JD, Buluran KB, Lawenko RB, Estorninos EM, Binia A, Sprenger N. Dynamics of human milk oligosaccharides in early lactation and relation with growth and appetitive traits of Filipino breastfed infants. Sci Rep. 2022 Oct 15;12(1):17304. doi: 10.1038/s41598-022-22244-7.

  PMID: 36243744 DERIVED

Study Officials

• Elvira M Estorninos, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 29, 2017
• Study Start: January 22, 2018
• Primary Completion: October 24, 2018
• Study Completion: December 11, 2018
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

PH (1)