GrowthPhase 3PétuniaNCT00920166
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
A Phase 3 study testing Pétunia 1 and Regular formula in people with Growth, run by Sodilac at 4 sites in France.
Trial summary
The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic. Read more about this study
- Who is it for?
- Ages Up to 8 days
- Conditions the study is for
- Growth
- What is being tested?
- Pétunia 1 and Regular formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2007to Mar 2008
- 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 8 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term health newborn infant with gestational age ranging from 37 to 42 weeks
- Eutrophic
- Non breastfed children
- Apgar score > 5 to 7 minutes
Who cannot join
- Infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study
- Evidence of protein cow milk allergy
- Infant presenting lactose intolerance
- Newborn whose parents did not provide informed consent
- Newborn currently participating in another trial
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU d'Angers
Angers, 49933
CHU de Nantes
Nantes, 44093
Hôpital Saint Vincent de Paul (AP-HP)
Paris, 75014
Hôpital de la Pitié Salpétrière
Paris, 75651
About this study
Official title: Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.
Read the detailed description
This prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic, in term infants.
Term infants with a gestational age ranging from 37 to 42 weeks and whose parents chose formula feeding were enrolled during their first eight days of life.
Both parents provided informed written consent. Infants were randomly assigned to receive either the new test formula or a control, a regular formula adapted for term infants (Modilac®1). The control formula is formulated to meet the nutritional needs of infants.
For each neonates, neonatal parameters were collected.
5 visits took place : V1 (inclusion), V2 (randomization), V3 (1 month), V4 (3 months) and V5 (6 months). During each visit, the investigator filled in observational book the anthropometric parameters (weight, height, head circumference, BMI) and pieces of information collected 3 days before by the parents (gastrointestinal tolerance parameters, daily infant behaviour and milk consumption). Global parents' contentment was evaluated as well.
In two investigation centers, at the end of the 6th month, immuno-allergic test was realised.
Stools were collected at the end of the first and sixth month from diapers, for microbiological analysis and measurements of faecal inflammatory markers.
- Conditions
- Growth
- Being tested
- Pétunia 1, Regular formula
- Keywords
- Infant formula, Alpha-lactalbumin, Symbiotic, Allergy, Gastrointestinal tolerance, Bacterial colonization, Faecal IgA analysis
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pétunia 1Dietary supplement
Also called Modilac Pétunia 1
Infant formula used for non breastfed children
Regular formulaDietary supplement
Also called Modilac 1
Infant formula used for non breastfed children
| Study group | Role | What they receive |
|---|---|---|
| Modilac Pétunia 1 | Experimental | Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic Receives: Dietary Supplement: Pétunia 1 |
| Modilac 1 | Active comparator | Regular milk Receives: Dietary Supplement: Regular formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Parameters
Measured: 1, 3 and 6 months
Secondary outcomes (4)
Sensitization or allergy
Measured: 1, 3 and 6 months
Atopic diseases (eczema atopic, asthma, allergic rhinitis)
Measured: 1, 3 and 6 months
Describe the intestinal flora according to the nutrition group
Measured: 1 and 6 months
Clinical Tolerance
Measured: 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startFeb 2007
- Primary completionMar 2008
- Study completionMar 2008
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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodilac
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean Christophe Rozé, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920166
- Sponsor's protocol ID
- PET-CL3-001
- Acronym
- Pétunia
- Status last verified
- Jun 2009
- First submitted
- 12 Jun 2009
- Last updated
- 15 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Roze JC, Barbarot S, Butel MJ, Kapel N, Waligora-Dupriet AJ, De Montgolfier I, Leblanc M, Godon N, Soulaines P, Darmaun D, Rivero M, Dupont C. An alpha-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial. Br J Nutr. 2012 Jun;107(11):1616-22. doi: 10.1017/S000711451100479X. Epub 2011 Nov 14.
PubMed 22079177
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
- ClinicalTrials.gov ID
- NCT00920166
- Acronym / sponsor ID
- Pétunia / PET-CL3-001
- Conditions
- Growth
- Keywords
- Infant formula, Alpha-lactalbumin, Symbiotic, Allergy, Gastrointestinal tolerance, Bacterial colonization, Faecal IgA analysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- SodilacIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Jun 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 the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.
Detailed description
This prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic, in term infants.
Term infants with a gestational age ranging from 37 to 42 weeks and whose parents chose formula feeding were enrolled during their first eight days of life.
Both parents provided informed written consent. Infants were randomly assigned to receive either the new test formula or a control, a regular formula adapted for term infants (Modilac®1). The control formula is formulated to meet the nutritional needs of infants.
For each neonates, neonatal parameters were collected.
5 visits took place : V1 (inclusion), V2 (randomization), V3 (1 month), V4 (3 months) and V5 (6 months). During each visit, the investigator filled in observational book the anthropometric parameters (weight, height, head circumference, BMI) and pieces of information collected 3 days before by the parents (gastrointestinal tolerance parameters, daily infant behaviour and milk consumption). Global parents' contentment was evaluated as well.
In two investigation centers, at the end of the 6th month, immuno-allergic test was realised.
Stools were collected at the end of the first and sixth month from diapers, for microbiological analysis and measurements of faecal inflammatory markers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modilac Pétunia 1 | Experimental | Dietary Supplement: Pétunia 1Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic |
| Modilac 1 | Active comparator | Dietary Supplement: Regular formulaRegular milk |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term health newborn infant with gestational age ranging from 37 to 42 weeks
- Eutrophic
- Non breastfed children
- Apgar score > 5 to 7 minutes
Key exclusion criteria (5 listed)
- Infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study
- Evidence of protein cow milk allergy
- Infant presenting lactose intolerance
- Newborn whose parents did not provide informed consent
- Newborn currently participating in another trial
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 |
|---|---|---|
| Pétunia 1Also: Modilac Pétunia 1Infant formula used for non breastfed children | Dietary supplement | Modilac Pétunia 1 |
| Regular formulaAlso: Modilac 1Infant formula used for non breastfed children | Dietary supplement | Modilac 1 |
Primary outcome
Growth Parameters
Time frame: 1, 3 and 6 months
4 secondary outcomes
Sensitization or allergy
Time frame: 1, 3 and 6 months
Atopic diseases (eczema atopic, asthma, allergic rhinitis)
Time frame: 1, 3 and 6 months
Describe the intestinal flora according to the nutrition group
Time frame: 1 and 6 months
Clinical Tolerance
Time frame: 1 and 6 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 15 Jun 2009.
- Derived from this study: PubMed 22079177Roze JC, Barbarot S, Butel MJ, Kapel N, Waligora-Dupriet AJ, De Montgolfier I, Leblanc M, Godon N, Soulaines P, Darmaun D, Rivero M, Dupont C. An alpha-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial. Br J Nutr. 2012 Jun;107(11):1616-22. doi: 10.1017/S000711451100479X. Epub 2011 Nov 14.
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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 Christophe Rozé, PhD principal investigator
Nantes University Hospital
4 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 Pétunia 1 and Regular formula in people with Growth, run by Sodilac at 4 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 4 inclusion and 5 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 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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: 1, 3 and 6 months). 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 NCT00920166, 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 Jun 2009.