Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula

NCT05618704 | Completed

• 1 other identifier: SBB21R&38227
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Growth

  16 weeks

• Cow's milk related symptoms

  16 weeks

• Gastrointestinal tolerance

  16 weeks

Study Arms (1)

Hydrolyzed protein infant formula

EXPERIMENTAL

All subjects will take the hydrolyzed protein infant formula

Dietary Supplement: Hydrolyzed protein infant formula

Interventions

Hydrolyzed protein infant formula DIETARY_SUPPLEMENT

The subjects will take the formula for 16 weeks

Hydrolyzed protein infant formula

Eligibility Criteria

• Age: 0 Days - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants \<8 months of age.
• Infants with a clinical diagnosis of Cow's Milk Allergy (CMA) per local hospital practice, including any of the following criteria:
• 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
• 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
• History of CoMiSS® score \>10 indicating symptoms are likely cow's milk allergic prior to study entry
• History of positive result of an oral food challenge with cow's milk prior to study entry
• 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.
• \. 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.
• Parents / guardians confirm their intention not to administer any products containing cow's milk protein during the study.
• Expected to consume the specified age-dependent minimum amount of study product per day during the study.
• Expected to require a milk substitute for CMA management for at least 16 weeks.
• Written informed consent provided by parents / guardians, according to local law.

You may not qualify if:

• Birth weight-for-age z-score \<-2 Standard Deviation (SD) or \>+2SD.
• Infants \<37 weeks gestation requiring specific premature formula at the time of study entry.
• 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.
• 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).
• Infants with diagnosis of rice allergy or known allergy to any of the ingredients in the study product.
• Investigator's uncertainty about the willingness or ability of the parents / guardians 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.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Promed Medical Centre

Krakow, Poland

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm, open label, interventional, multi-centre study

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 16, 2022
• Study Start: March 16, 2023
• Primary Completion: October 14, 2024
• Study Completion: May 12, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)