HealthyNCT00665938
Followup of Infants Fed Non-routine Infant Formula
A study testing Infant formula in people with Healthy, run by Mead Johnson Nutrition.
Trial summary
The purpose of this study is to compare physical development of infants fed one of three study formulas. Read more about this study
- Who is it for?
- Ages 4 to 4 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
- 183 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Dec 2011
- 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 4 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Completed Study 3369-5
Who cannot join
- None
About this study
The purpose of this study is to compare physical development of infants fed one of three study formulas.
- Conditions
- Healthy
- Being tested
- Infant formula
- Keywords
- Physical development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
Also called No other names are applicable to the 3 intervention arms
Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL)
Arm 2. partially hydrolyzed infant formula with probiotics
Arm 3. extensively hydrolyzed infant formula with probiotics
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Other: Infant formula |
| 2 | Experimental | Not described Receives: Other: Infant formula |
| 3 | Experimental | Not described Receives: Other: Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieved weight
Measured: 5 years
Secondary outcomes (1)
Tolerance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2011
- Study completionDec 2011
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Deolinda Scalabrin, MD, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665938
- Sponsor's protocol ID
- 3369-6
- Other IDs
- 3369-6
- Status last verified
- Jan 2012
- First submitted
- 28 Mar 2008
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Followup of Infants Fed Non-routine Infant Formula
- ClinicalTrials.gov ID
- NCT00665938
- Acronym / sponsor ID
- 3369-6
- Conditions
- Healthy
- Keywords
- Physical development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Apr 2008 (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 compare physical development of infants fed one of three study formulas.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Infant formula |
| 2 | Experimental | Other: Infant formula |
| 3 | Experimental | Other: Infant formula |
Who may qualify
- Ages
- 4 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Completed Study 3369-5
Key exclusion criteria (1 listed)
- None
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 formulaAlso: No other names are applicable to the 3 intervention armsArm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL) Arm 2. partially hydrolyzed infant formula with probiotics Arm 3. extensively hydrolyzed infant formula with probiotics | Other | 1, 2, 3 |
Primary outcome
Achieved weight
Time frame: 5 years
1 secondary outcome
Tolerance
Time frame: 1 year
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 31 Jan 2012.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Deolinda Scalabrin, MD study director
Mead Johnson Nutrition
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula in people with Healthy, run by Mead Johnson Nutrition.
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 1 inclusion and 1 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 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Achieved weight (time frame: 5 years). 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 31 Jan 2012.