Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula (STORY)

A Single Arm, Open Label Intervention Study of a Hydrolyzed Protein Formula to Evaluate Growth, Safety and Tolerance in Infants With a Clinical Diagnosis of Cow's Milk Allergy

This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein formula.

Study Overview

• Status: Recruiting
• Conditions: Cow Milk Allergy
• Intervention / Treatment: Dietary supplement: Hydrolyzed protein infant formula

Detailed Description

The main purpose of this study is to demonstrate adequate growth over a 16-week intervention period in cow's milk allergic infants receiving a hydrolyzed protein formula.

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danone Nutricia Research; Phone Number: +31 30 2095 000; Email: register.clinicalresearchnutricia@danone.com

Study Locations

• Poland
  • Kraków, Poland
    • Recruiting
    • Promed Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 8 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Infants <8 months of age.

2. Infants with a clinical diagnosis of Cow's Milk Allergy (CMA) per local hospital practice, including any of the following criteria:

   1. Based on clinical examination with a careful history, parent-reported symptoms suggestive of CMA, and disappearance of the symptoms when cow's milk was eliminated from the diet for at least two weeks prior to study entry
   2. Based on clinical examination with a careful history, parent-reported symptoms suggestive of CMA, and disappearance of the symptoms while being breastfed with maternal cow's milk protein elimination diet for at least two weeks prior to study entry
   3. History of CoMiSS® score >10 indicating symptoms are likely cow's milk allergic prior to study entry
   4. History of positive result of an oral food challenge with cow's milk prior to study entry
   5. Presence of specific Immunoglobulin E (IgE) to cow's milk protein based on skin prick test (wheel size ≥3mm) or radio-allergosorbent-test (RAST) (>0.7 kilounit per liter (kU/L)) prior to or on the day of study entry.
3. 3. Infants that are still on dairy-derived extensively hydrolysed formula, amino acid-based formula, hydrolysed rice protein formula, soy-based formula or being breastfed by mothers who are on cow's milk protein elimination diet at study entry.
4. Parents / guardians confirm their intention not to administer any products containing cow's milk protein during the study.
5. Expected to consume the specified age-dependent minimum amount of study product per day during the study.
6. Expected to require a milk substitute for CMA management for at least 16 weeks.
7. Written informed consent provided by parents / guardians, according to local law.

Exclusion Criteria:

1. Birth weight-for-age z-score <-2 Standard Deviation (SD) or >+2SD.
2. Infants <37 weeks gestation requiring specific premature formula at the time of study entry.
3. Infants with severe concurrent illness and/or have undergone gastrointestinal surgery such as bowel resection or stoma placement and/or with Down syndrome or other syndromes where functional gastrointestinal disorders are common.
4. Infants that are more suitable to use Amino Acid Formula (AAF) as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using extensively Hydrolysed Formula (eHF)), faltering growth / failure to thrive, or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
5. Infants with diagnosis of rice allergy or known allergy to any of the ingredients in the study product.
6. Investigator's uncertainty about the willingness or ability of the parents / guardians to comply with the protocol requirements.
7. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrolyzed protein infant formula; All subjects will take the hydrolyzed protein infant formula	Dietary supplement: Hydrolyzed protein infant formula; The subjects will take the formula for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate growth	Proportion of subjects with growth classified as adequate (by interpreting WHO z-scores weight-for-age and weight-for-length)	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	Weight, length, head circumference, BMI and corresponding World health Organization (WHO) z-scores	16 weeks
Cow's milk related symptoms	CoMiSS and parent completed diary	16 weeks
Gastrointestinal tolerance	Parent completed diary, incidence of gastrointestinal adverse effects. Tolerance will be evaluated on the basis of the number of gastrointestinal events including diarrhea, constipation, bloating, distension, nausea, vomiting, burping, flatulence and regurgitation and abdominal discomfort or pain reported for subjects during their participation in the study.	16 weeks
Concentration of markers of mineral status in blood	Zinc (Zn); Calcium (Ca); Phosphate (P); Ferritin (Fe); Magnesium (Mg)	16 weeks
Study product intake (ml/day) and complementary foods/drinks (food diary)	Parent completed diary	3 days prior to the last visit
Study product appreciation	Parent completed questionnaire (questions with scales e.g., strongly agree - strongly disagree)	16 weeks

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 16, 2022

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

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: SBB21R&38227

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