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Completed

NCT Number: NCT00997971

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

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.

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Key information

Conditions

Growth Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aix-les-Bains, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modilac Rose 1

Other

Infant formula used for non-breastfed children

Primary outcomes

  1. Growth parameters

    Time frame: 2nd, 4th and 6th months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sodilac

Industry

Registry information

Official study title

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

Acronym: Rose

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 20, 2009
Registry last updated
Oct 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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