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

Allergy Clinical Trial

— Rose  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997971
• Other study ID #: ROS-CL3-001
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2009
• Last updated: October 19, 2009
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: October 2009
• Source: Sodilac
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Allergy
• Growth

Intervention

Other:
• Modilac Rose 1
Infant formula used for non-breastfed children

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sodilac

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth parameters		2nd, 4th and 6th months	Yes
Secondary	Clinical Tolerance		3 days before the 2nd and 6th months	No
Secondary	Atopic diseases (eczema atopic, asthma)		2nd and 6th months	Yes