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

Not Applicable

Terminated

• Conditions: Cow's Milk Allergy
• Interventions: Other: eHF; Other: HRF

• Registration Number: NCT02405923
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2014-07-01
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-01
• Primary Completion: 2019-04-11
• Study Completion: 2019-04-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eHF (Extensive Hydrolysed Formula)	eHF	Extensive Hydrolysed Cow's Milk Protein Formula (eHF)
HRF (Rice formula)	HRF	Hydrolyzed Rice Protein Formula (HRF)

Primary Outcome Measures

Name	Time	Method
Growing change	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

Name	Time	Method
Nutritional adequacy	6 months	To monitor nutritional adequacy in terms of anthropometrics and proteic status.
Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge)	6 months	To evaluate the acquisition of tolerance between both groups.
Contaminants	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).

Trial Locations

Locations (5)

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain

Hospital Materno Infantil de Málaga; 🇪🇸 Málaga, Spain

Hôpital Saint Vincent-de-Paul; 🇫🇷 Lille, Lille Cedex, France

Hospital Infantil Virgen del Rocío; 🇪🇸 Sevilla, Andalucía, Spain

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, Cedex 14, France