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Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy (GRITO-14)

Primary Purpose

Cow's Milk Allergy

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HRF
eHF
Sponsored by
Laboratorios Ordesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow's Milk Allergy

Eligibility Criteria

undefined - 10 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects up to 10 months old with clinical history of a reaction to cow's milk protein and/or confirmed diagnosis (up to grade II anaphylaxis) of allergy to cow's milk protein by one of the following criteria, within two months prior to the baseline visit are eligible to enter the study:

    • Negative or positive skin prick tests ( fresh milk, rice, casein hydrolysates)
    • Negative or positive specific IgE for cow's milk proteins (alphalactalbumine, betalactoglobuline, caseine and cow's milk)
    • Negative or positive Milk Atopy Patch Test
    • Positive Double Blind Placebo Control Food Challenge (DBPCFC) with cow milk
  • Gestational Age 37-42 weeks inclusive
  • Apgar SCORE >7 at 5 minutes
  • Singleton birth
  • Birth weight ≥2.500 g
  • Written informed consent

Exclusion Criteria:

  • Previous signs of allergy to any extensively hydrolysed formula
  • Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow's milk e.g. history of anaphylactic reaction, graded more or equal to grade III, as this could not be compatible with an allocation to the eHF group
  • Daily formula intake < 100 ml
  • Major congenital malformations or neonatal diseases
  • Severe concurrent or chronic diseases
  • Intrauterine growth retardation
  • Neonatal infections ( e.g. CMV, HIV)
  • Simultaneous participation in other clinical trials
  • Parents not signing written informed consent
  • Unable to adhere to protocol requirements or study visits due to non compliance of parents or caregivers.
  • Liver, kidney, haematological abnormalities as judged clinically by investigators at baseline.

Sites / Locations

  • Hôpital Necker-Enfants Malades
  • Hôpital Saint Vincent-de-Paul
  • Hospital Infantil Virgen del Rocío
  • Hospital Materno Infantil de Málaga
  • Hospital Universitari i Politècnic La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HRF (Rice formula)

eHF (Extensive Hydrolysed Formula)

Arm Description

Hydrolyzed Rice Protein Formula (HRF)

Extensive Hydrolysed Cow's Milk Protein Formula (eHF)

Outcomes

Primary Outcome Measures

Growing change
To evaluate the children growth using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of CMPA.

Secondary Outcome Measures

Nutritional adequacy
To monitor nutritional adequacy in terms of anthropometrics and proteic status.
Contaminants
To monitor the presence of possible contaminants in urine and hair samples coming from both infant formula groups (only in children exclusively or predominantly formula fed; ideally recruited from 0 to 6 months). Moreover the presence of possible contaminants will be evaluated also in powder formula and formula from baby bottles (only in 12 patients, randomly chosen).
Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge)
To evaluate the acquisition of tolerance between both groups.

Full Information

First Posted
November 13, 2014
Last Updated
July 15, 2019
Sponsor
Laboratorios Ordesa
Collaborators
Sprim Advanced Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02405923
Brief Title
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
Acronym
GRITO-14
Official Title
Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitment longer than expected and without the expected success
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
April 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa
Collaborators
Sprim Advanced Life Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).
Detailed Description
The main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by Ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of CMA (Cow Milk Allergy) from cow's milk protein allergy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRF (Rice formula)
Arm Type
Experimental
Arm Description
Hydrolyzed Rice Protein Formula (HRF)
Arm Title
eHF (Extensive Hydrolysed Formula)
Arm Type
Placebo Comparator
Arm Description
Extensive Hydrolysed Cow's Milk Protein Formula (eHF)
Intervention Type
Other
Intervention Name(s)
HRF
Other Intervention Name(s)
HRF-1 from 0 to 6 months of age, HRF-2 from 6 months of age onwards
Intervention Description
The subject will take the formula for a period of 12 months.
Intervention Type
Other
Intervention Name(s)
eHF
Other Intervention Name(s)
eHF-1 from 0 to 6 months of age, eHF-2 from 6 months of age onwards
Intervention Description
The subject will take the formula for a period of 12 months.
Primary Outcome Measure Information:
Title
Growing change
Description
To evaluate the children growth using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of CMPA.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Nutritional adequacy
Description
To monitor nutritional adequacy in terms of anthropometrics and proteic status.
Time Frame
6 months
Title
Contaminants
Description
To monitor the presence of possible contaminants in urine and hair samples coming from both infant formula groups (only in children exclusively or predominantly formula fed; ideally recruited from 0 to 6 months). Moreover the presence of possible contaminants will be evaluated also in powder formula and formula from baby bottles (only in 12 patients, randomly chosen).
Time Frame
6 months
Title
Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge)
Description
To evaluate the acquisition of tolerance between both groups.
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects up to 10 months old with clinical history of a reaction to cow's milk protein and/or confirmed diagnosis (up to grade II anaphylaxis) of allergy to cow's milk protein by one of the following criteria, within two months prior to the baseline visit are eligible to enter the study: Negative or positive skin prick tests ( fresh milk, rice, casein hydrolysates) Negative or positive specific IgE for cow's milk proteins (alphalactalbumine, betalactoglobuline, caseine and cow's milk) Negative or positive Milk Atopy Patch Test Positive Double Blind Placebo Control Food Challenge (DBPCFC) with cow milk Gestational Age 37-42 weeks inclusive Apgar SCORE >7 at 5 minutes Singleton birth Birth weight ≥2.500 g Written informed consent Exclusion Criteria: Previous signs of allergy to any extensively hydrolysed formula Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow's milk e.g. history of anaphylactic reaction, graded more or equal to grade III, as this could not be compatible with an allocation to the eHF group Daily formula intake < 100 ml Major congenital malformations or neonatal diseases Severe concurrent or chronic diseases Intrauterine growth retardation Neonatal infections ( e.g. CMV, HIV) Simultaneous participation in other clinical trials Parents not signing written informed consent Unable to adhere to protocol requirements or study visits due to non compliance of parents or caregivers. Liver, kidney, haematological abnormalities as judged clinically by investigators at baseline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireia Mireia, MD
Organizational Affiliation
Laboratorios Ordesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
State/Province
Cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
Hôpital Saint Vincent-de-Paul
City
Lille
State/Province
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Hospital Infantil Virgen del Rocío
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Materno Infantil de Málaga
City
Málaga
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

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Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy

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