Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
Pétunia
Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
1 other identifier
interventional
97
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2007
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedJune 15, 2009
June 1, 2009
1.1 years
June 12, 2009
June 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Growth Parameters
1, 3 and 6 months
Secondary Outcomes (4)
Sensitization or allergy
1, 3 and 6 months
Atopic diseases (eczema atopic, asthma, allergic rhinitis)
1, 3 and 6 months
Describe the intestinal flora according to the nutrition group
1 and 6 months
Clinical Tolerance
1 and 6 months
Study Arms (2)
Modilac Pétunia 1
EXPERIMENTALFormula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic
Modilac 1
ACTIVE COMPARATORRegular milk
Interventions
Infant formula used for non breastfed children
Infant formula used for non breastfed children
Eligibility Criteria
You may qualify if:
- Term health newborn infant with gestational age ranging from 37 to 42 weeks
- Eutrophic
- Non breastfed children
- Apgar score \> 5 to 7 minutes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sodilaclead
Study Sites (4)
CHU d'Angers
Angers, 49933, France
CHU de Nantes
Nantes, 44093, France
Hôpital Saint Vincent de Paul (AP-HP)
Paris, 75014, France
Hôpital de la Pitié Salpétrière
Paris, 75651, France
Related Publications (1)
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.
PMID: 22079177DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Christophe Rozé, PhD
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 15, 2009
Study Start
February 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
June 15, 2009
Record last verified: 2009-06