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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Lactalis
Sponsor:
Collaborator:
Biosearch S.A.
Information provided by (Responsible Party):
Lactalis
ClinicalTrials.gov Identifier:
NCT01909661
First received: July 18, 2013
Last updated: August 28, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Cow Milk Protein Sensitivity
Tolerance
Growth Failure
Other: Damira/Celia peptide hydrolyzed casein
Other: Picot riz/Celia rice/Sanutri arroz
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Lactalis:

Primary Outcome Measures:
  • Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption. [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    Tolerance is absence of clinical signs.


Secondary Outcome Measures:
  • Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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.


Other Outcome Measures:
  • Volume of infant formula consumed by the infants [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Volume of infant formula consumed by the infants in 3 months


Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909661

Contacts
Contact: Jacqueline Brasy +33299475084 jacqueline.brasy@lactalis.fr

Locations
Spain
Biosearch S.A. Recruiting
Granada, Spain, 18004
Contact: Juristo Fonollá Joya    +34 958240288 / +34 6188063    Juristo.FonollaJoya@biosearchlife.com   
Contact: Maria Paz Diaz Ropero    +34 958 230 469    MariaPaz.DiazRopero@biosearchlife.com   
Sponsors and Collaborators
Lactalis
Biosearch S.A.
  More Information

No publications provided

Responsible Party: Lactalis
ClinicalTrials.gov Identifier: NCT01909661     History of Changes
Other Study ID Numbers: LRD - 2013 - JUNGLO
Study First Received: July 18, 2013
Last Updated: August 28, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Lactalis:
allergy
Cow's milk protein
Tolerance
Efficacy
Infants' growth

Additional relevant MeSH terms:
Failure to Thrive
Milk Hypersensitivity
Signs and Symptoms
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014