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.

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

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

Treatments tested in this trial

  • Test Formula
  • Control Formula

Treatment groups

104 Participants
are divided into 2 treatment groups