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

L

Lactalis

Status and phase

Completed
Phase 2

Conditions

Cow Milk Protein Sensitivity
Growth Failure
Tolerance

Treatments

Other: Picot riz/Celia rice/Sanutri arroz
Other: Damira/Celia peptide hydrolyzed casein

Study type

Interventional

Funder types

Industry

Identifiers

NCT01909661
LRD - 2013 - JUNGLO

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

All

Ages

Under 9 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

114 participants in 2 patient groups

Damira/Celia peptide hydrolyzed casein
Experimental group
Description:
Extensively Hydrolyzed (EH)casein infant formula
Treatment:
Other: Damira/Celia peptide hydrolyzed casein
Picot riz/Celia rice/Sanutri arroz
Experimental group
Description:
Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula
Treatment:
Other: Picot riz/Celia rice/Sanutri arroz

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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