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

October 19, 2009 updated by: Sodilac

Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth parameters
Time Frame: 2nd, 4th and 6th months
2nd, 4th and 6th months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Tolerance
Time Frame: 3 days before the 2nd and 6th months
3 days before the 2nd and 6th months
Atopic diseases (eczema atopic, asthma)
Time Frame: 2nd and 6th months
2nd and 6th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sodilac

Investigators

  • Principal Investigator: Jean-Philippe Girardet, PhD, Hôpîtal d'Enfants Armand Trousseau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (Estimate)

October 20, 2009

Study Record Updates

Last Update Posted (Estimate)

October 20, 2009

Last Update Submitted That Met QC Criteria

October 19, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROS-CL3-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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