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OpenTrials
Completed

NCT Number: NCT03387124

Breastfeeding Study

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

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Key information

Conditions

Age range

21 day–26 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Asian Hospital and Medical Center

City of Muntinlupa, Alabang, 1780, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfed infants

Other

Breastmilk

Primary outcomes

  1. Stool Consistency Score

    Time frame: 155 days

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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