search
Back to results

Hypoallergenicity of a Hydrolyzed Protein Infant Formula (HYPO STORY)

Primary Purpose

Cow's Milk Allergy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hydrolyzed protein infant formula
commercially available hypoallergenic infant formula
Sponsored by
Nutricia Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cow's Milk Allergy focused on measuring Infant formula, Hypoallergenicity

Eligibility Criteria

0 Days - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Pediatric hospital Bambino Gesù

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

hydrolized protein formula

Control formula

Arm Description

hydrolysed protein formula

commercially available hypoallergenic infant formula

Outcomes

Primary Outcome Measures

Hypoallergenicity
The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge.

Secondary Outcome Measures

Full Information

First Posted
December 23, 2022
Last Updated
February 15, 2023
Sponsor
Nutricia Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05731206
Brief Title
Hypoallergenicity of a Hydrolyzed Protein Infant Formula
Acronym
HYPO STORY
Official Title
Study to Assess Hypoallergenicity of a Hydrolysed Protein Formula in Children With Confirmed Cow's Milk Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy
Keywords
Infant formula, Hypoallergenicity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover assignment and an observational, single-arm, follow-up.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hydrolized protein formula
Arm Type
Experimental
Arm Description
hydrolysed protein formula
Arm Title
Control formula
Arm Type
Placebo Comparator
Arm Description
commercially available hypoallergenic infant formula
Intervention Type
Other
Intervention Name(s)
Hydrolyzed protein infant formula
Intervention Description
Hydrolyzed protein infant formula
Intervention Type
Other
Intervention Name(s)
commercially available hypoallergenic infant formula
Intervention Description
commercially available hypoallergenic infant formula
Primary Outcome Measure Information:
Title
Hypoallergenicity
Description
The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge.
Time Frame
25-35 days
Other Pre-specified Outcome Measures:
Title
Relevant parameters routinely collected in the clinic
Description
e.g serum IgE results
Time Frame
25-35 days
Title
Incidence, seriousness, severity and relatedness of Adverse Events
Description
Safety and tolerance parameters
Time Frame
25-35 days
Title
Demographics characteristics
Description
Demographics characteristics
Time Frame
at baseline
Title
Relevant parameters routinely collected in the clinic
Description
e.g. skin prick test results
Time Frame
25-35 days
Title
Birth length
Description
cm
Time Frame
at baseline
Title
Birth weight
Description
g
Time Frame
at baseline
Title
anthropometrics
Description
e.g. weight and lenght
Time Frame
at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Pediatric hospital Bambino Gesù
City
Rome
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Fiocchi, Prof

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hypoallergenicity of a Hydrolyzed Protein Infant Formula

We'll reach out to this number within 24 hrs