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

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

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).

Study Overview

• Status: Terminated
• Conditions: Cow's Milk Allergy
• Intervention / Treatment: Other: HRF; Other: eHF

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cedex 14
    • Paris, Cedex 14, France, 75674
      • Hôpital Necker-Enfants Malades
  • Lille Cedex
    • Lille, Lille Cedex, France, 59020
      • Hopital Saint Vincent-de-Paul
• Spain
  • Málaga, Spain
    • Hospital Materno Infantil de Málaga
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Andalucía
    • Sevilla, Andalucía, Spain, 41013
      • Hospital Infantil Virgen del Rocío

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional adequacy	To monitor nutritional adequacy in terms of anthropometrics and proteic status.	6 months
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).	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: Mireia Mireia, MD, Laboratorios Ordesa

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): April 11, 2019
• Study Completion (Actual): April 11, 2019

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: GRITO-14