GrowthPhase 3RoseNCT00997971
Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein
A Phase 3 study testing Modilac Rose 1 in people with Growth and Allergy, run by Sodilac at 9 sites in France.
Trial summary
The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula. Read more about this study
- Who is it for?
- Ages Up to 1 month
- What is being tested?
- Modilac Rose 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 9 sitesFrance
- Study dates
- Sep 2007to Aug 2009
- Phase
- Phase 3
- 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 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term health infants with gestational age ranging from 37 to 42 weeks
- Infants less than 1 month old
- Non breastfed children at the inclusion
- Growth parameter normal
- Apgar score > 5 to 7 minutes
- Change in the formula because of digestive troubles (colics, gas, regurgitation) or risks of allergy
- Absence of metabolic, nervous or digestive troubles
- Absence of digestive haemorrhage, apnea or dizzy turn
Who cannot join
- Partial breastfed children
- Infants presenting a cow's milk protein allergy
- Infants currently participating in another trial
- Infants presenting an organic disease involving medicinal or surgical treatment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Study site
Aix-les-Bains, 73100
Study site
Asnières, 92600
Study site
Besançon, 25000
Study site
Boulogne-Billancourt, 92100
Study site
Caen, 14000
Study site
Écully, 69130
Study site
Lyon, 69005
Study site
Meaux, 77100
Study site
Saint-Priest-en-Jarez, 42270
About this study
Official title: Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants
The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.
Read the detailed description
This objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the experimental formula.
Parents provide informed written consent.
4 visits are forecasted in pediatric surgeries: V1(inclusion), V2 (2 months), V3 (4 months) and V4 (6 months). The last visit corresponds to the beginning of the food diversification decided by the pediatrician. Ideally it takes place at 6 months. If the food diversification starts at 4 months, then V3 and V4 constitute the same last visit.
- Being tested
- Modilac Rose 1
- Keywords
- Hydrolysed rice protein formula, Cow's milk protein allergy, Infant formula, Gastrointestinal tolerance
- Medical subject headings
- Hypersensitivity, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modilac Rose 1Other
Infant formula used for non-breastfed children
| Study group | Role | What they receive |
|---|---|---|
| Modilac Rose 1 | Experimental | Infant formula with partially hydrolysed rice protein Receives: Other: Modilac Rose 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth parameters
Measured: 2nd, 4th and 6th months
Secondary outcomes (2)
Clinical Tolerance
Measured: 3 days before the 2nd and 6th months
Atopic diseases (eczema atopic, asthma)
Measured: 2nd and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startSep 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodilac
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Philippe Girardet, PhD, Principal investigator, Hôpital d'enfants Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997971
- Sponsor's protocol ID
- ROS-CL3-001
- Acronym
- Rose
- Status last verified
- Oct 2009
- First submitted
- 14 Sep 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants
- ClinicalTrials.gov ID
- NCT00997971
- Acronym / sponsor ID
- Rose / ROS-CL3-001
- Keywords
- Hydrolysed rice protein formula, Cow's milk protein allergy, Infant formula, Gastrointestinal tolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- SodilacIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Oct 2009 (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 assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.
Detailed description
This objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the experimental formula.
Parents provide informed written consent.
4 visits are forecasted in pediatric surgeries: V1(inclusion), V2 (2 months), V3 (4 months) and V4 (6 months). The last visit corresponds to the beginning of the food diversification decided by the pediatrician. Ideally it takes place at 6 months. If the food diversification starts at 4 months, then V3 and V4 constitute the same last visit.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modilac Rose 1 | Experimental | Other: Modilac Rose 1Infant formula with partially hydrolysed rice protein |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Term health infants with gestational age ranging from 37 to 42 weeks
- Infants less than 1 month old
- Non breastfed children at the inclusion
- Growth parameter normal
- Apgar score > 5 to 7 minutes
Key exclusion criteria (4 listed)
- Partial breastfed children
- Infants presenting a cow's milk protein allergy
- Infants currently participating in another trial
- Infants presenting an organic disease involving medicinal or surgical treatment
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 |
|---|---|---|
| Modilac Rose 1Infant formula used for non-breastfed children | Other | Modilac Rose 1 |
Primary outcome
Growth parameters
Time frame: 2nd, 4th and 6th months
2 secondary outcomes
Clinical Tolerance
Time frame: 3 days before the 2nd and 6th months
Atopic diseases (eczema atopic, asthma)
Time frame: 2nd and 6th months
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 20 Oct 2009.
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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.
Jean-Philippe Girardet, PhD principal investigator
Hôpital d'enfants Armand Trousseau
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modilac Rose 1 in people with Growth and Allergy, run by Sodilac at 9 sites in France.
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 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 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 parameters (time frame: 2nd, 4th and 6th 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 20 Oct 2009.