NCT00997971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
Last Updated

October 20, 2009

Status Verified

October 1, 2009

Enrollment Period

1.9 years

First QC Date

September 14, 2009

Last Update Submit

October 19, 2009

Conditions

GrowthAllergy

Keywords

Hydrolysed rice protein formulaCow's milk protein allergyInfant formulaGastrointestinal tolerance

Outcome Measures

Primary Outcomes (1)

  • Growth parameters

    2nd, 4th and 6th months

Secondary Outcomes (2)

  • Clinical Tolerance

    3 days before the 2nd and 6th months

  • Atopic diseases (eczema atopic, asthma)

    2nd and 6th months

Study Arms (1)

Modilac Rose 1

EXPERIMENTAL

Infant formula with partially hydrolysed rice protein

Other: Modilac Rose 1

Interventions

Modilac Rose 1OTHER

Infant formula used for non-breastfed children

Modilac Rose 1

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term health infants with gestational age ranging from 37 to 42 weeks
  • Infants less than 1 month old
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Aix-les-Bains, 73100, France

Location

Unknown Facility

Asnières, 92600, France

Location

Unknown Facility

Besançon, 25000, France

Location

Unknown Facility

Boulogne-Billancourt, 92100, France

Location

Unknown Facility

Caen, 14000, France

Location

Unknown Facility

Écully, 69130, France

Location

Unknown Facility

Lyon, 69005, France

Location

Unknown Facility

Meaux, 77100, France

Location

Unknown Facility

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

HypersensitivityMilk Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System DiseasesFood HypersensitivityHypersensitivity, Immediate

Study Officials

  • Jean-Philippe Girardet, PhD

    Hôpital d'enfants Armand Trousseau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2009

First Posted

October 20, 2009

Study Start

September 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 20, 2009

Record last verified: 2009-10

Locations

FR(9)