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

Cow's Milk Allergy Clinical Trial

— GRITO-14  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02405923
• Other study ID #: GRITO-14
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: April 11, 2019

Study information

• Verified date: July 2019
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: April 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• HRF
The subject will take the formula for a period of 12 months.
• eHF
The subject will take the formula for a period of 12 months.

Locations

Country	Name	City	State
France	Hôpital Saint Vincent-de-Paul	Lille	Lille Cedex
France	Hôpital Necker-Enfants Malades	Paris	Cedex 14
Spain	Hospital Materno Infantil de Málaga	Málaga
Spain	Hospital Infantil Virgen del Rocío	Sevilla	Andalucía
Spain	Hospital Universitari i Politècnic La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	Sprim Advanced Life Sciences

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nutritional adequacy	To monitor nutritional adequacy in terms of anthropometrics and proteic status.	6 months
Secondary	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
Secondary	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