Infant Term BirthNCT03387124
Breastfeeding Study
An observational study of Infant Term Birth, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial summary
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants. Read more about this study
- Who is it for?
- Ages 21 to 26 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Term Birth
- What is being tested?
- Breastfed infants
- How many people
- 75 participants
- Where
- 1 sitePhilippines
- Study dates
- 22 Jan 2018to 11 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 26 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: 75 healthy term exclusively breastfed infants
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Asian Hospital and Medical Center
City of Muntinlupa, Alabang, 1780
About this study
Official title: Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.
Read the 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.
- Conditions
- Infant Term Birth
- Being tested
- Breastfed infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfed infantsOther
Breastmilk
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Consistency Score
Measured: 155 days
Secondary outcomes (4)
Fecal Microbiota Composition
Measured: 155 days
Changes in Weight from baseline to 155 days
weight (kg)
Measured: 155 days
Changes in Length from baseline to 155 days
length (cm)
Measured: 155 days
Changes in Head Circumference from baseline to 155 days
head circumference (cm)
Measured: 155 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start22 Jan 2018
- Primary completion24 Oct 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant Term BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elvira M Estorninos, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387124
- Sponsor's protocol ID
- 16.23.INF
- Status last verified
- Apr 2019
- First submitted
- 21 Dec 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36243744
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants
- ClinicalTrials.gov ID
- NCT03387124
- Acronym / sponsor ID
- 16.23.INF
- Conditions
- Infant Term Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 26 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 75 healthy term exclusively breastfed infants
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfed infantsBreastmilk | Other | – |
Primary outcome
Stool Consistency Score
Time frame: 155 days
4 secondary outcomes
Fecal Microbiota Composition
Time frame: 155 days
Changes in Weight from baseline to 155 days
Time frame: 155 days
Changes in Length from baseline to 155 days
Time frame: 155 days
Changes in Head Circumference from baseline to 155 days
Time frame: 155 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 36243744Samuel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvira M Estorninos, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Term Birth, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool Consistency Score (time frame: 155 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03387124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.