Breastfeeding Study

Infant Term Birth Clinical Trial

Official title:

Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387124
• Other study ID #: 16.23.INF
• Status: Completed
• Start date: January 22, 2018
• Est. completion date: December 11, 2018

Study information

• Verified date: April 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 11, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 26 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Term Birth

Intervention

Other:
• Breastfed infants
Breastmilk

Locations

Country	Name	City	State
Philippines	Asian Hospital and Medical Center	Muntinlupa	Alabang

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Consistency Score		155 days
Secondary	Fecal Microbiota Composition		155 days
Secondary	Changes in Weight from baseline to 155 days	weight (kg)	155 days
Secondary	Changes in Length from baseline to 155 days	length (cm)	155 days
Secondary	Changes in Head Circumference from baseline to 155 days	head circumference (cm)	155 days