Clinical trial NCT02405923: Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
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
Overall status: TERMINATED
Phase: NA
Conditions: Cow's Milk Allergy
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2015-04-01
Enrollment: 117
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Growing change
timeFrame: 6 months
Secondary outcomes:
measure: Nutritional adequacy
timeFrame: 6 months
measure: Contaminants
timeFrame: 6 months
measure: Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge)
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
state: Cedex 14
city: Lille
country: France
facility: Hôpital Saint Vincent-de-Paul
state: Lille Cedex
city: Sevilla
country: Spain
facility: Hospital Infantil Virgen del Rocío
state: Andalucía
city: Málaga
country: Spain
facility: Hospital Materno Infantil de Málaga
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Laboratorios Ordesa
name: Mireia Mireia, MD
role: PRINCIPAL_INVESTIGATOR
References: