Hypoallergenicity of a Hydrolyzed Protein Infant Formula (HYPO STORY)

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

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

Study Overview

• Status: Suspended
• Conditions: Cow's Milk Allergy
• Intervention / Treatment: Other: Hydrolyzed protein infant formula; Other: commercially available hypoallergenic infant formula

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Pediatric hospital Bambino Gesù
    • Principal Investigator: Alessandro Fiocchi, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hydrolized protein formula; hydrolysed protein formula	Other: Hydrolyzed protein infant formula; Hydrolyzed protein infant formula
Placebo Comparator: Control formula; commercially available hypoallergenic infant formula	Other: commercially available hypoallergenic infant formula; commercially available hypoallergenic infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoallergenicity	The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge.	25-35 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relevant parameters routinely collected in the clinic	e.g serum IgE results	25-35 days
Incidence, seriousness, severity and relatedness of Adverse Events	Safety and tolerance parameters	25-35 days
Demographics characteristics	Demographics characteristics	at baseline
Relevant parameters routinely collected in the clinic	e.g. skin prick test results	25-35 days
Birth length	cm	at baseline
Birth weight	g	at baseline
anthropometrics	e.g. weight and lenght	at baseline

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Infant formula; Hypoallergenicity
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: SBB22R&40330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No