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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997971
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : October 20, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Growth Allergy Other: Modilac Rose 1 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants
Study Start Date : September 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Modilac Rose 1
Infant formula with partially hydrolysed rice protein
Other: Modilac Rose 1
Infant formula used for non-breastfed children

Primary Outcome Measures :
  1. Growth parameters [ Time Frame: 2nd, 4th and 6th months ]

Secondary Outcome Measures :
  1. Clinical Tolerance [ Time Frame: 3 days before the 2nd and 6th months ]
  2. Atopic diseases (eczema atopic, asthma) [ Time Frame: 2nd and 6th months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00997971

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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
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Principal Investigator: Jean-Philippe Girardet, PhD Hôpital d'enfants Armand Trousseau
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Responsible Party: Pr Jean-Philippe Girardet (Principal investigator), Hôpital d'enfants Armand Trousseau Identifier: NCT00997971    
Other Study ID Numbers: ROS-CL3-001
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: October 20, 2009
Last Verified: October 2009
Keywords provided by Sodilac:
Hydrolysed rice protein formula
Cow's milk protein allergy
Infant formula
Gastrointestinal tolerance
Additional relevant MeSH terms:
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Immune System Diseases