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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2019-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula

NCT06830681

Cow Milk Protein Allergy

TERMINATED NA

Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.

NCT06633250

Cow Milk Protein Allergy

RECRUITING NA

Hydrolysed Rice Formula Study

NCT06288503

Cow's Milk Protein Allergy

RECRUITING NA

Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas

NCT01909661

Cow Milk Protein Sensitivity Tolerance Growth Failure

COMPLETED PHASE2

Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula

NCT05618704

Cow Milk Allergy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cow's Milk Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HRF (Rice formula)

Hydrolyzed Rice Protein Formula (HRF)

Group Type EXPERIMENTAL

HRF

Intervention Type OTHER

The subject will take the formula for a period of 12 months.

eHF (Extensive Hydrolysed Formula)

Extensive Hydrolysed Cow's Milk Protein Formula (eHF)

Group Type PLACEBO_COMPARATOR

eHF

Intervention Type OTHER

The subject will take the formula for a period of 12 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HRF

The subject will take the formula for a period of 12 months.

Intervention Type OTHER

eHF

The subject will take the formula for a period of 12 months.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HRF-1 from 0 to 6 months of age HRF-2 from 6 months of age onwards eHF-1 from 0 to 6 months of age eHF-2 from 6 months of age onwards

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

10 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No