Hypoallergenicity of a Hydrolyzed Protein Infant Formula

Cow's Milk Allergy Clinical Trial

— HYPO STORY  

Official title:

Study to Assess Hypoallergenicity of a Hydrolysed Protein Formula in Children With Confirmed Cow's Milk Allergy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05731206
• Other study ID #: SBB22R&40330
• Status: Suspended
• Phase: N/A
• Start date: July 31, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: April 2024
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 29
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• Hydrolyzed protein infant formula
Hydrolyzed protein infant formula
• commercially available hypoallergenic infant formula
commercially available hypoallergenic infant formula

Locations

Country	Name	City	State
Italy	Pediatric hospital Bambino Gesù	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relevant parameters routinely collected in the clinic	e.g serum IgE results	25-35 days
Other	Incidence, seriousness, severity and relatedness of Adverse Events	Safety and tolerance parameters	25-35 days
Other	Demographics characteristics	Demographics characteristics	at baseline
Other	Relevant parameters routinely collected in the clinic	e.g. skin prick test results	25-35 days
Other	Birth length	cm	at baseline
Other	Birth weight	g	at baseline
Other	anthropometrics	e.g. weight and lenght	at baseline
Primary	Hypoallergenicity	The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge.	25-35 days