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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
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Angers, Frankrike, 49933
- CHU d'Angers
-
Nantes, Frankrike, 44093
- CHU de Nantes
-
Paris, Frankrike, 75651
- Hôpital de la Pitié Salpêtrière
-
Paris, Frankrike, 75014
- Hôpital Saint Vincent de Paul (AP-HP)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Modilac Pétunia 1
Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic
|
Infant formula used for non breastfed children
Andra namn:
|
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Aktiv komparator: Modilac 1
Regular milk
|
Infant formula used for non breastfed children
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Growth Parameters
Tidsram: 1, 3 and 6 months
|
1, 3 and 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Sensitization or allergy
Tidsram: 1, 3 and 6 months
|
1, 3 and 6 months
|
|
Atopic diseases (eczema atopic, asthma, allergic rhinitis)
Tidsram: 1, 3 and 6 months
|
1, 3 and 6 months
|
|
Describe the intestinal flora according to the nutrition group
Tidsram: 1 and 6 months
|
1 and 6 months
|
|
Clinical Tolerance
Tidsram: 1 and 6 months
|
1 and 6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jean Christophe Rozé, PhD, CHU de Nantes
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- PET-CL3-001
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