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Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein (Rose)

This study has been completed.
Sponsor:
Information provided by:
Sodilac
ClinicalTrials.gov Identifier:
NCT00997971
First received: September 14, 2009
Last updated: October 19, 2009
Last verified: October 2009
History of Changes
  Purpose

The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.


Condition Intervention Phase
Growth
Allergy
 Other: Modilac Rose 1
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sodilac:

Primary Outcome Measures:
  • Growth parameters [ Time Frame: 2nd, 4th and 6th months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical Tolerance [ Time Frame: 3 days before the 2nd and 6th months ] [ Designated as safety issue: No ]
  • Atopic diseases (eczema atopic, asthma) [ Time Frame: 2nd and 6th months ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modilac Rose 1
Infant formula with partially hydrolysed rice protein
 Other: Modilac Rose 1
Infant formula used for non-breastfed children
Other Name: Modilac Rose 1

Detailed Description:

This objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the experimental formula.

Parents provide informed written consent.

4 visits are forecasted in pediatric surgeries: V1(inclusion), V2 (2 months), V3 (4 months) and V4 (6 months). The last visit corresponds to the beginning of the food diversification decided by the pediatrician. Ideally it takes place at 6 months. If the food diversification starts at 4 months, then V3 and V4 constitute the same last visit.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term health infants with gestational age ranging from 37 to 42 weeks
  • Infants less than 1 month old
  • Non breastfed children at the inclusion
  • Growth parameter normal
  • Apgar score > 5 to 7 minutes
  • Change in the formula because of digestive troubles (colics, gas, regurgitation) or risks of allergy
  • Absence of metabolic, nervous or digestive troubles
  • Absence of digestive haemorrhage, apnea or dizzy turn

Exclusion Criteria:

  • Partial breastfed children
  • Infants presenting a cow's milk protein allergy
  • Infants currently participating in another trial
  • Infants presenting an organic disease involving medicinal or surgical treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997971

Locations
France
Aix les bains, France, 73100
Asnieres, France, 92600
Besancon, France, 25000
Boulogne Billancourt, France, 92100
Caen, France, 14000
Ecully, France, 69130
Lyon, France, 69005
Meaux, France, 77100
St Priest en Jarez, France, 42270
Sponsors and Collaborators
Sodilac
Investigators
Principal Investigator: Jean-Philippe Girardet, PhD Hôpital d'enfants Armand Trousseau
  More Information

No publications provided

Responsible Party: Pr Jean-Philippe Girardet (Principal investigator), Hôpital d'enfants Armand Trousseau
ClinicalTrials.gov Identifier: NCT00997971     History of Changes
Other Study ID Numbers: ROS-CL3-001
Study First Received: September 14, 2009
Last Updated: October 19, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sodilac:
Hydrolysed rice protein formula
Cow's milk protein allergy
Infant formula
Gastrointestinal tolerance

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013