Clinical trial NCT05731206: Hypoallergenicity of a Hydrolyzed Protein Infant Formula
Official title: Study to Assess Hypoallergenicity of a Hydrolysed Protein Formula in Children With Confirmed Cow's Milk Allergy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cow's Milk Allergy
Keywords: Infant formula
Hypoallergenicity
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 29
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover assignment and an observational, single-arm, follow-up.
Primary purpose: OTHER

Brief summary: Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.

Detailed description: The study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.

Eligibility criteria: Inclusion Criteria:

1. Infants and children aged up to 3 years.
2. Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by:

   1. Physician-supervised double-blind oral food challenge; or
   2. Physician-supervised open oral food challenge that elicited objective immediate allergic reactions; or
   3. Report of convincing allergic reaction to cow's milk or a milk-containing food product, in conjunction with presence of milk-specific serum Immunoglobuline E (IgE) level \> 0.7 kilounit per liter (U/L) or by skin prick test (wheal size ≥ 3mm).
3. Willing to switch to a different hypoallergenic formula
4. On elimination diet (commercially available, hypoallergenic infant formula ) and free of clinical symptoms, or with controlled stable symptoms, for at least one week preceding the study (challenge day #1).
5. Expected minimal consumption of 144ml of test product/day during the open challenge.
6. Written informed consent provided by parents/guardians, according to local law.

Exclusion Criteria:

1. Infants/children who are more suitable to use AAF as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using eHF) or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
2. Diagnosis or known allergy to any of the ingredients in the test product.
3. Congenital anomalies which will interfere with oral feeding or gastrointestinal tract, other chronic diseases (including but not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease), major gastrointestinal disease/abnormalities, or any other medical condition that could interfere with the identification of allergic reactions.
4. (Twin / triplet) sibling of an infant/child already participating in the study.
5. Investigator's uncertainty about the willingness or ability of the subject and his/her parents to comply with the protocol requirements.
6. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
7. Employees and/or children/family members or relatives of employees of Nutricia Research or the participating study sites.

Primary outcomes:
measure: Hypoallergenicity
timeFrame: 25-35 days
Secondary outcomes:
Other outcomes:
measure: Relevant parameters routinely collected in the clinic
timeFrame: 25-35 days
measure: Incidence, seriousness, severity and relatedness of Adverse Events
timeFrame: 25-35 days
measure: Demographics characteristics
timeFrame: at baseline
measure: Relevant parameters routinely collected in the clinic
timeFrame: 25-35 days
measure: Birth length
timeFrame: at baseline
measure: Birth weight
timeFrame: at baseline
measure: anthropometrics
timeFrame: at baseline
Locations:
city: Rome
country: Italy
facility: Pediatric hospital Bambino Gesù
Study officials:
References: