Hypoallergenicity of a Hydrolyzed Protein Infant Formula

NCT05731206 | Suspended

• 1 other identifier: SBB22R&40330
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cow's Milk Allergy

Keywords

Infant formula; Hypoallergenicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Relevant parameters routinely collected in the clinic

  25-35 days

• Incidence, seriousness, severity and relatedness of Adverse Events

  25-35 days

• Demographics characteristics

  at baseline

Study Arms (2)

hydrolized protein formula

EXPERIMENTAL

hydrolysed protein formula

Other: Hydrolyzed protein infant formula

Control formula

PLACEBO COMPARATOR

commercially available hypoallergenic infant formula

Other: commercially available hypoallergenic infant formula

Interventions

Hydrolyzed protein infant formula OTHER

Hydrolyzed protein infant formula

hydrolized protein formula

commercially available hypoallergenic infant formula OTHER

commercially available hypoallergenic infant formula

Control formula

Eligibility Criteria

• Age: 0 Days - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants and children aged up to 3 years.
• Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by:
• Physician-supervised double-blind oral food challenge; or
• Physician-supervised open oral food challenge that elicited objective immediate allergic reactions; or
• 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).
• Willing to switch to a different hypoallergenic formula
• 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).
• Expected minimal consumption of 144ml of test product/day during the open challenge.
• Written informed consent provided by parents/guardians, according to local law.

You may not qualify if:

• 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).
• Diagnosis or known allergy to any of the ingredients in the test product.
• 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.
• (Twin / triplet) sibling of an infant/child already participating in the study.
• Investigator's uncertainty about the willingness or ability of the subject and his/her parents to comply with the protocol requirements.
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
• Employees and/or children/family members or relatives of employees of Nutricia Research or the participating study sites.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Pediatric hospital Bambino Gesù

Rome, Italy

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover assignment and an observational, single-arm, follow-up.

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: February 16, 2023
• Study Start: July 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)