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

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

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.

Study Overview

• Status: Completed
• Conditions: Growth Failure; Tolerance; Cow Milk Protein Sensitivity
• Intervention / Treatment: Other: Damira/Celia peptide hydrolyzed casein; Other: Picot riz/Celia rice/Sanutri arroz

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18004
    • Biosearch S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Damira/Celia peptide hydrolyzed casein; Extensively Hydrolyzed (EH)casein infant formula	Other: Damira/Celia peptide hydrolyzed casein
Experimental: Picot riz/Celia rice/Sanutri arroz; Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula	Other: Picot riz/Celia rice/Sanutri arroz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of infant formula consumed by the infants	Volume of infant formula consumed by the infants in 3 months	3 months

Collaborators and Investigators

• Sponsor: Lactalis
• Collaborators: Biosearch S.A.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 16, 2015
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Efficacy; Tolerance; allergy; Cow's milk protein; Infants' growth
• Additional Relevant MeSH Terms: Failure to Thrive; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: LRD - 2013 - JUNGLO