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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00920166
Other study ID # PET-CL3-001
Secondary ID
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 (ModilacĀ®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


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
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