Clinical trial NCT03387124: Breastfeeding Study
Official title: Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Term Birth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-12-29
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 75 healthy term exclusively 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.

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

Primary outcomes:
measure: Stool Consistency Score
timeFrame: 155 days
Secondary outcomes:
measure: Fecal Microbiota Composition
timeFrame: 155 days
measure: Changes in Weight from baseline to 155 days
timeFrame: 155 days
measure: Changes in Length from baseline to 155 days
timeFrame: 155 days
measure: Changes in Head Circumference from baseline to 155 days
timeFrame: 155 days
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
state: Alabang
Study officials:
affiliation: University of Alberta
name: Elvira M Estorninos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.