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

Tolerance Clinical Trial

— JUNGLO  

Official title:

Tolerancia a 2 fórmulas de Leche Infantil Altamente Hidrolizadas en Base a proteínas de Arroz y a caseína en niños Con Alergia a Las proteínas de Leche de Vaca

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909661
• Other study ID #: LRD - 2013 - JUNGLO
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2013
• Last updated: April 16, 2015
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2013
• Source: Lactalis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 9 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cow Milk Protein Sensitivity
• Failure to Thrive
• Growth Failure
• Milk Hypersensitivity
• Tolerance

Intervention

Other:
• Damira/Celia peptide hydrolyzed casein

• Picot riz/Celia rice/Sanutri arroz

Locations

Country	Name	City	State
Spain	Biosearch S.A.	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Lactalis	Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Volume of infant formula consumed by the infants	Volume of infant formula consumed by the infants in 3 months	3 months	No
Primary	Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.	Tolerance is absence of clinical signs.	24h	Yes
Secondary	Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement.	Evaluate during 3 months of consumption the effectiveness of the formulas, in terms of : infant growth, through anthropometric measures (body weight, length and head circumference); allergy symptoms, through the improvement of the allergy symptoms.	3 months	Yes