HealthyNCT02405572
Feeding Tolerance Evaluation
A study testing infant formula in people with Healthy, run by Société des Produits Nestlé (SPN) at 2 sites in United States.
Trial summary
Crossover study of 2 infant formulas Read more about this study
- Who is it for?
- Ages Up to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Mar 2016
- 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 Up to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Full-term (> 37 weeks gestation)
- 0-2 months (birth-56 days) of age on enrollment
- Infant exclusively formula-fed for at least 2 days prior to enrollment
- Having obtained his/her legal representative's informed consent
Who cannot join
- Known or suspected cow-milk allergy
- Congenital illness or malformation
- Significant prenatal and/or postnatal disease
- Currently participating in another clinical study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tanner Clinic
Layton, Utah, 84041
Pedia Research
Owensboro, Kentucky, 47630
About this study
Crossover study of 2 infant formulas
Read the detailed description
Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.
- Conditions
- Healthy
- Being tested
- infant formula
- Keywords
- formula-fed, infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant formulaOther
infant formulas
| Study group | Role | What they receive |
|---|---|---|
| Formula 1 | Active comparator | infant formula Receives: Other: infant formula |
| Formula 2 | Active comparator | infant formula Receives: Other: infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
stool consistency
caregivers will document on diary records
Measured: 2 weeks
Secondary outcomes (6)
spit-up pattern
caregivers will document on diary records
Measured: 2 weeks
formula intake
caregivers will document on diary records
Measured: 2 weeks
adverse events
assessed throughout the study
Measured: 2 weeks
stool pattern
caregivers will document on diary records
Measured: 2 weeks
mood
caregivers will document on diary records
Measured: 2 weeks
sleep pattern
caregivers will document on diary records
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rich Litov, PhD, Principal investigator, Pedia Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405572
- Sponsor's protocol ID
- 14.32.US.INF
- Status last verified
- May 2016
- First submitted
- 23 Feb 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Tolerance Evaluation
- ClinicalTrials.gov ID
- NCT02405572
- Acronym / sponsor ID
- 14.32.US.INF
- Conditions
- Healthy
- Keywords
- formula-fed, infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (actual)
- First posted
- 1 Apr 2015 (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.
Crossover study of 2 infant formulas
Detailed description
Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formula 1 | Active comparator | Other: infant formulainfant formula |
| Formula 2 | Active comparator | Other: infant formulainfant formula |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy newborn infant
- Full-term (> 37 weeks gestation)
- 0-2 months (birth-56 days) of age on enrollment
- Infant exclusively formula-fed for at least 2 days prior to enrollment
- Having obtained his/her legal representative's informed consent
Key exclusion criteria (4 listed)
- Known or suspected cow-milk allergy
- Congenital illness or malformation
- Significant prenatal and/or postnatal disease
- Currently participating in another clinical study
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 |
|---|---|---|
| infant formulainfant formulas | Other | Formula 1, Formula 2 |
Primary outcome
stool consistency
Time frame: 2 weeks
caregivers will document on diary records
6 secondary outcomes
spit-up pattern
Time frame: 2 weeks
formula intake
Time frame: 2 weeks
adverse events
Time frame: 2 weeks
stool pattern
Time frame: 2 weeks
mood
Time frame: 2 weeks
sleep pattern
Time frame: 2 weeks
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 12 May 2016.
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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.
Rich Litov, PhD principal investigator
Pedia Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infant formula in people with Healthy, run by Société des Produits Nestlé (SPN) at 2 sites in United States.
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 5 inclusion and 4 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 (time frame: 2 weeks). 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 12 May 2016.