HealthyNCT01476397
Probiotic Formula and Infant Growth
A study testing Test infant formula in people with Healthy, run by Société des Produits Nestlé (SPN) at 8 sites in United States.
Trial summary
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups. Read more about this study
- Who is it for?
- Ages 11 to 17 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 8 sitesUnited States
- Study dates
- Dec 2011to Oct 2013
- 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 11 to 17 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Full-term
- Birth weight > 2500 and < 4500 g
- 14±3 days of age on enrollment
- Exclusively formula-fed, singleton birth
- Having obtained his/her legal representative's informed consent
Who cannot join
- Known or suspected cow-milk allergy
- Congenital illness or malformation that may affect infant feeding and/or growth
- Significant prenatal and/or postnatal disease
- Any readmission to hospital prior to enrollment
- Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
- Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
- Currently participating in another clinical study
- Cannot be expected to comply with treatment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Kentucky Pediatric Adult Research
Bardstown, Kentucky, 40004
PMG Research of Bristol
Bristol, Tennessee, 37620
Medical University of South Carolina
Charleston, South Carolina, 29425
Pediatrics & Adolescent Medicine
Marietta, Georgia, 30189
North Scottsdale Pediatric Associates
Scottsdale, Arizona, 85258
Pediatric Healthcare of Northwest Houston
Tomball, Texas, 77375
Advanced Pediatrics
Vienna, Virginia, 22180
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
About this study
Official title: ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.
- Conditions
- Healthy
- Being tested
- Control infant formula, Test infant formula
- Keywords
- full-term, formula-fed infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control infant formulaOther
partially hydrolyzed whey infant formula consumed ad libitum throughout study
Test infant formulaOther
partially hydrolyzed whey formula with probiotic
| Study group | Role | What they receive |
|---|---|---|
| control infant formula | Active comparator | partially hydrolyzed whey infant formula Receives: Other: Control infant formula |
| test infant formula | Experimental | partially hydrolyzed whey infant formula with probiotic Receives: Other: Test infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth
weight gain assessed monthly
Measured: 4 months
Secondary outcomes (5)
other growth
Length, head circumference will be measured at monthly visits
Measured: 4 months
adverse events
all adverse events will be documented throughout the study
Measured: 4 months
stool characteristics
stool frequency, color, consistency
Measured: throughout study
spit-up
frequency of spit-up as reported by caregivers
Measured: throughout study
vomit
frequency of vomitting as reported by caregivers
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionOct 2013
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
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476397
- Sponsor's protocol ID
- 10.01.US.INF
- Status last verified
- Nov 2014
- First submitted
- 14 Nov 2011
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS
- ClinicalTrials.gov ID
- NCT01476397
- Acronym / sponsor ID
- 10.01.US.INF
- Conditions
- Healthy
- Keywords
- full-term, formula-fed infants
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Nov 2011 (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.
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control infant formula | Active comparator | Other: Control infant formulapartially hydrolyzed whey infant formula |
| test infant formula | Experimental | Other: Test infant formulapartially hydrolyzed whey infant formula with probiotic |
Who may qualify
- Ages
- 11 to 17 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy newborn infant
- Full-term
- Birth weight > 2500 and < 4500 g
- 14±3 days of age on enrollment
- Exclusively formula-fed, singleton birth
Key exclusion criteria (8 listed)
- Known or suspected cow-milk allergy
- Congenital illness or malformation that may affect infant feeding and/or growth
- Significant prenatal and/or postnatal disease
- Any readmission to hospital prior to enrollment
- Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
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 |
|---|---|---|
| Control infant formulapartially hydrolyzed whey infant formula consumed ad libitum throughout study | Other | control infant formula |
| Test infant formulapartially hydrolyzed whey formula with probiotic | Other | test infant formula |
Primary outcome
growth
Time frame: 4 months
weight gain assessed monthly
5 secondary outcomes
other growth
Time frame: 4 months
adverse events
Time frame: 4 months
stool characteristics
Time frame: throughout study
spit-up
Time frame: throughout study
vomit
Time frame: throughout study
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 4 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test infant formula in people with Healthy, run by Société des Produits Nestlé (SPN) at 8 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 6 inclusion and 8 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
growth (time frame: 4 months). 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 4 Nov 2014.