GrowthNCT00655720
The Effects on Growth of a Non-Routine Infant Formula
A study testing infant formula in people with Growth, run by Mead Johnson Nutrition.
Trial summary
A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics Read more about this study
- Who is it for?
- Ages 12 to 16 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to May 2007
- 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 12 to 16 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infant
- Solely formula fed
- 14 days of age
Who cannot join
- History of underlying disease
- Evidence of formula intolerance
- Current illness
About this study
Official title: The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants
A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics
- Conditions
- Growth
- Being tested
- infant formula
- Keywords
- infant formula
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 for any of the intervention arms
- hydrolyzed infant formula without probiotics
- hydrolyzed infant formula with probiotics
- 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.
Growth (weight)
Measured: 106 days
Secondary outcomes (1)
Tolerance
Measured: 106 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startMar 2006
- Primary completionMay 2007
- Study completionMay 2007
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 GrowthStudies 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
- 293 participants (actual)
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
- NCT00655720
- Sponsor's protocol ID
- 3369-5
- Other IDs
- 3369-5
- Status last verified
- Apr 2008
- First submitted
- 28 Mar 2008
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Scalabrin DM, Johnston WH, Hoffman DR, P'Pool VL, Harris CL, Mitmesser SH. Growth and tolerance of healthy term infants receiving hydrolyzed infant formulas supplemented with Lactobacillus rhamnosus GG: randomized, double-blind, controlled trial. Clin Pediatr (Phila). 2009 Sep;48(7):734-44. doi: 10.1177/0009922809332682. Epub 2009 Mar 4.
PubMed 19264721
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants
- ClinicalTrials.gov ID
- NCT00655720
- Acronym / sponsor ID
- 3369-5
- Conditions
- Growth
- Keywords
- infant formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 10 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.
A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics
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
- 12 to 16 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Term infant
- Solely formula fed
- 14 days of age
Key exclusion criteria (3 listed)
- History of underlying disease
- Evidence of formula intolerance
- Current illness
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 for any of the intervention arms1. hydrolyzed infant formula without probiotics 2. hydrolyzed infant formula with probiotics 3. hydrolyzed infant formula with probiotics | Other | 1, 2, 3 |
Primary outcome
Growth (weight)
Time frame: 106 days
1 secondary outcome
Tolerance
Time frame: 106 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 15 Apr 2008.
- Derived from this study: PubMed 19264721Scalabrin DM, Johnston WH, Hoffman DR, P'Pool VL, Harris CL, Mitmesser SH. Growth and tolerance of healthy term infants receiving hydrolyzed infant formulas supplemented with Lactobacillus rhamnosus GG: randomized, double-blind, controlled trial. Clin Pediatr (Phila). 2009 Sep;48(7):734-44. doi: 10.1177/0009922809332682. Epub 2009 Mar 4.
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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.
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 Growth, 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 3 inclusion and 3 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 15 Apr 2008. 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?
Growth (weight) (time frame: 106 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 NCT00655720, 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 15 Apr 2008.