Health TrialsbyHealthPanel

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.

ConditionCow Milk Protein Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 8
SponsorSociété des Produits Nestlé (SPN)

About this trial

The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR]), if applicable)

Infant gestational age ≥ 37 completed weeks

Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg

Singleton birth

Disqualifiers

History of intolerance to eHF formula

Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)

Major gastrointestinal disease / abnormalities (other than CMPA)

Known or suspected lactose intolerance or malabsorption

Trial design

Design model

Parallel

Treatments tested in this trial

  • Test Formula

    Other intervention

    Hydrolyzed rice protein formula

  • Control Formula

    Other intervention

    Commercially available extensively hydrolyzed cow's milk formula

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Test FormulaExperimental treatment 1 intervention
Group B: Control FormulaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Weight-for-age z-score at 4 months post-enrollment

Weight measured in g and expressed in z scores according to the World Health Organization (WHO) Child Growth Standards.

Time frame
From enrollment to 4 months post-enrollment

Secondary outcomes

1

Weight

Weight (g and z-scores)

Time frame
Monthly from enrollment to 4 months post-enrollment
2

Length

Length (cm and z-scores)

Time frame
Monthly from enrollment to 4 months post-enrollment
3

Head circumference

Head circumference (cm and z-scores)

Time frame
At enrollmentn and 4 months post-enrollment
4

Tibia lenght

Tibia (cm)

Time frame
At enrollmentn and 4 months post-enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Société des Produits Nestlé (SPN)

Lead sponsor

Source ClinicalTrials.gov
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