Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants

Growth Clinical Trial

— Pétunia  

Official title:

Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920166
• Other study ID #: PET-CL3-001
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2009
• Last updated: June 12, 2009
• Start date: February 2007
• Est. completion date: March 2008

Study information

• Verified date: June 2009
• Source: Sodilac
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

Inclusion Criteria:

• Term health newborn infant with gestational age ranging from 37 to 42 weeks

• Eutrophic

• Non breastfed children

• Apgar score > 5 to 7 minutes

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Growth

Intervention

Dietary Supplement:
• Pétunia 1
Infant formula used for non breastfed children
• Regular formula
Infant formula used for non breastfed children

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Nantes	Nantes
France	Hôpital de la Pitié Salpétrière	Paris
France	Hôpital Saint Vincent de Paul (AP-HP)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sodilac

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth Parameters		1, 3 and 6 months	Yes
Secondary	Sensitization or allergy		1, 3 and 6 months	No
Secondary	Atopic diseases (eczema atopic, asthma, allergic rhinitis)		1, 3 and 6 months	No
Secondary	Describe the intestinal flora according to the nutrition group		1 and 6 months	No
Secondary	Clinical Tolerance		1 and 6 months	No