Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas

NCT ID: NCT01909661

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-08-31

Brief Summary

The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.

Conditions

Cow Milk Protein Sensitivity; Tolerance; Growth Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Damira/Celia peptide hydrolyzed casein

Extensively Hydrolyzed (EH)casein infant formula

Group Type: EXPERIMENTAL

Damira/Celia peptide hydrolyzed casein

Intervention Type: OTHER

Picot riz/Celia rice/Sanutri arroz

Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula

Group Type: EXPERIMENTAL

Picot riz/Celia rice/Sanutri arroz

Intervention Type: OTHER

Interventions

Damira/Celia peptide hydrolyzed casein

Intervention Type: OTHER

Picot riz/Celia rice/Sanutri arroz

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Full term healthy newborns (37-42 Weeks gestation)
• Weight at birth ≥ 2500 g
• Aged between birth to 9 months
• Symptoms of allergy (Skin or digetive)
• Suspicion of cow milk protein allergy
• Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study
• Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study

Exclusion Criteria

• Children who have returned to breastfeeding
• Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
• In the past 15 days, treatment or medication likely to :

• induce confusion in the allergy tets (ex. : Skin Prick Test) and / or
• mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, …)
• Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
• Children who show signs of malnutrition, or prolonged diarrhea
• Children whose parents show no willingness to comply with study requirements
• Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein.

• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosearch S.A.

INDUSTRY

Sponsor Role: collaborator

Lactalis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biosearch S.A.

Granada, , Spain

Countries

Spain

Other Identifiers

LRD - 2013 - JUNGLO

Identifier Type: -

Identifier Source: org_study_id