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

Laboratorios Ordesa

Status: Terminated

Conditions: Cow's Milk Allergy

Treatments: Other: eHF; Other: HRF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02405923

GRITO-14

Details and patient eligibility

About

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).

Full 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.

Enrollment: 117 patients

Sex: All

Ages: Under 10 months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 2 patient groups, including a placebo group

HRF (Rice formula)

Experimental group

Description:

Hydrolyzed Rice Protein Formula (HRF)

Treatment:

Other: HRF

eHF (Extensive Hydrolysed Formula)

Placebo Comparator group

Description:

Extensive Hydrolysed Cow's Milk Protein Formula (eHF)

Treatment:

Other: eHF