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Completed

NCT Number: NCT01909661

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

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.

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Key information

Age range

Up to 9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Biosearch S.A.

Granada, 18004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Damira/Celia peptide hydrolyzed casein

Other

Picot riz/Celia rice/Sanutri arroz

Other

Primary outcomes

  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 outcomes

  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 outcomes

  1. Volume of infant formula consumed by the infants

    Time frame: 3 months

    Volume of infant formula consumed by the infants in 3 months

Sponsors and collaborators

Lead sponsor

Lactalis

Industry

Collaborators

  • Biosearch S.A.

Registry information

Official study 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

Acronym: JUNGLO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2013
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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