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

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ClinicalTrials.gov Identifier: NCT02405923
Recruitment Status : Terminated (recruitment longer than expected and without the expected success)
First Posted : April 1, 2015
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Laboratorios Ordesa

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).

Condition or disease Intervention/treatment Phase
Cow's Milk Allergy Other: HRF Other: eHF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Casein

Arm Intervention/treatment
Experimental: HRF (Rice formula)
Hydrolyzed Rice Protein Formula (HRF)
Other: HRF
The subject will take the formula for a period of 12 months.
Other Names:
  • HRF-1 from 0 to 6 months of age
  • HRF-2 from 6 months of age onwards

Placebo Comparator: eHF (Extensive Hydrolysed Formula)
Extensive Hydrolysed Cow's Milk Protein Formula (eHF)
Other: eHF
The subject will take the formula for a period of 12 months.
Other Names:
  • eHF-1 from 0 to 6 months of age
  • eHF-2 from 6 months of age onwards




Primary Outcome Measures :
  1. Growing change [ Time Frame: 6 months ]
    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 :
  1. Nutritional adequacy [ Time Frame: 6 months ]
    To monitor nutritional adequacy in terms of anthropometrics and proteic status.

  2. Contaminants [ Time Frame: 6 months ]
    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).

  3. Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge) [ Time Frame: 6 months ]
    To evaluate the acquisition of tolerance between both groups.



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Ages Eligible for Study:   up to 10 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02405923


Locations
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France
Hôpital Necker-Enfants Malades
Paris, Cedex 14, France, 75674
Hôpital Saint Vincent-de-Paul
Lille, Lille Cedex, France, 59020
Spain
Hospital Infantil Virgen del Rocío
Sevilla, Andalucía, Spain, 41013
Hospital Materno Infantil de Málaga
Málaga, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Laboratorios Ordesa
Sprim Advanced Life Sciences
Investigators
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Principal Investigator: Mireia Mireia, MD Laboratorios Ordesa

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Responsible Party: Laboratorios Ordesa
ClinicalTrials.gov Identifier: NCT02405923     History of Changes
Other Study ID Numbers: GRITO-14
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action