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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01909661
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : April 17, 2015
Biosearch S.A.
Information provided by (Responsible Party):

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

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

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

Secondary Outcome Measures :
  1. Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement. [ Time Frame: 3 months ]

    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:
  1. Volume of infant formula consumed by the infants [ Time Frame: 3 months ]
    Volume of infant formula consumed by the infants in 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01909661

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Biosearch S.A.
Granada, Spain, 18004
Sponsors and Collaborators
Biosearch S.A.

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Responsible Party: Lactalis Identifier: NCT01909661     History of Changes
Other Study ID Numbers: LRD - 2013 - JUNGLO
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: July 2013
Keywords provided by Lactalis:
Cow's milk protein
Infants' growth
Additional relevant MeSH terms:
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Failure to Thrive
Signs and Symptoms
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action