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

Primary Purpose

Cow Milk Protein Sensitivity, Tolerance, Growth Failure

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Damira/Celia peptide hydrolyzed casein

Picot riz/Celia rice/Sanutri arroz

About this trial

This is an interventional treatment trial for Cow Milk Protein Sensitivity focused on measuring allergy, Cow's milk protein, Tolerance, Efficacy, Infants' growth

Eligibility Criteria

undefined - 9 Months (Child)All SexesDoes not accept 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.

Sites / Locations

Biosearch S.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Damira/Celia peptide hydrolyzed casein

Picot riz/Celia rice/Sanutri arroz

Arm Description

Extensively Hydrolyzed (EH)casein infant formula

Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01909661

First Posted

July 18, 2013

Last Updated

April 16, 2015

Sponsor

Lactalis

Collaborators

Biosearch S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01909661

Brief Title

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

Acronym

JUNGLO

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 Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lactalis

Collaborators

Biosearch S.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cow Milk Protein Sensitivity, Tolerance, Growth Failure

Keywords

allergy, Cow's milk protein, Tolerance, Efficacy, Infants' growth

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Damira/Celia peptide hydrolyzed casein

Arm Type

Experimental

Arm Description

Extensively Hydrolyzed (EH)casein infant formula

Arm Title

Picot riz/Celia rice/Sanutri arroz

Arm Type

Experimental

Arm Description

Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula

Intervention Type

Other

Intervention Name(s)

Damira/Celia peptide hydrolyzed casein

Intervention Type

Other

Intervention Name(s)

Picot riz/Celia rice/Sanutri arroz

Primary Outcome Measure Information:

Title

Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.

Description

Tolerance is absence of clinical signs.

Time Frame

24h

Secondary Outcome Measure Information:

Title

Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement.

Description

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Volume of infant formula consumed by the infants

Description

Volume of infant formula consumed by the infants in 3 months

Time Frame

3 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

9 Months

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Biosearch S.A.

City

Granada

ZIP/Postal Code

18004

Country

Spain

12. IPD Sharing Statement

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

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