Infant Term BirthNCT02670863
Safety and Efficacy Study
A study testing Experimental Infant Formula and Standard Infant Formula in people with 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 safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula. 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?
- Experimental Infant Formula and Standard Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 sitePhilippines
- Study dates
- 21 Jan 2016to May 2017
- Phase
- Interventional
- 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
Who may be able to join
- Written Informed Consent
- Infants whose parent(s)/LAR 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 are able to be contacted 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 >/= - 3 and </= +3 according to WHO Child Growth Standards
- Infants of parent(s)/LAR who have previously made the decision to formula feed 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 complementary 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 parents/LAR 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, 1780
About this study
Official title: Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial
The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.
Read the detailed description
Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.
- Conditions
- Infant Term Birth
- Being tested
- Experimental Infant Formula, Standard Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Infant FormulaOther
Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum
Standard Infant FormulaOther
Standard bovine milk-based term infant formula, fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infant Formula | Experimental | Experimental Infant Formula containing a prebiotic Receives: Other: Experimental Infant Formula |
| Standard Infant Formula | Active comparator | Standard bovine milk-based term infant formula Receives: Other: Standard Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
weight gain velocity
Measured: 150 days
Stool Consistency Score
Measured: 150 days
Secondary outcomes (5)
Weight
weight in grams
Measured: 150 days
Average Daily Stool Frequency
Measured: 150 days
Fecal Microbiota
Measured: 150 days
Fecal Markers
Measured: 150 days
Adverse Events
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start21 Jan 2016
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 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, Asian Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670863
- Sponsor's protocol ID
- 14.15.INF
- Status last verified
- Oct 2021
- First submitted
- 20 Jan 2016
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02670863
- Acronym / sponsor ID
- 14.15.INF
- Conditions
- Infant Term Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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 safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.
Detailed description
Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaExperimental Infant Formula containing a prebiotic |
| Standard Infant Formula | Active comparator | Other: Standard Infant FormulaStandard bovine milk-based term infant formula |
Who may qualify
- Ages
- 21 to 26 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Written Informed Consent
- Infants whose parent(s)/LAR 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 are able to be contacted 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 complementary 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 parents/LAR 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 |
|---|---|---|
| Experimental Infant FormulaStandard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum | Other | Experimental Infant Formula |
| Standard Infant FormulaStandard bovine milk-based term infant formula, fed ad libitum | Other | Standard Infant Formula |
Primary outcome
Growth
Time frame: 150 days
weight gain velocity
Stool Consistency Score
Time frame: 150 days
5 secondary outcomes
Weight
Time frame: 150 days
Average Daily Stool Frequency
Time frame: 150 days
Fecal Microbiota
Time frame: 150 days
Fecal Markers
Time frame: 150 days
Adverse Events
Time frame: 150 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 11 Oct 2021.
- 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
Asian Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant Formula and Standard Infant Formula in people with 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 11 Oct 2021. 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?
Growth (time frame: 150 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2021.