Breastfeeding Study

Completed

• Conditions: Infant Term Birth

• Registration Number: NCT03387124
• Lead Sponsor: Société des Produits Nestlé (SPN)

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 Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Study Start: 2018-01-22
• Primary Completion: 2018-10-24
• Study Completion: 2018-12-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stool Consistency Score	155 days

Secondary Outcome Measures

Name	Time	Method
Fecal Microbiota Composition	155 days
Changes in Head Circumference from baseline to 155 days	155 days	head circumference (cm)
Changes in Length from baseline to 155 days	155 days	length (cm)
Changes in Weight from baseline to 155 days	155 days	weight (kg)

Trial Locations

Locations (1)

Asian Hospital and Medical Center; 🇵🇭 Muntinlupa, Alabang, Philippines