Evaluating a hydrolyzed protein formula for infants with cow's milk allergy

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 study tests if a special protein formula can help infants with cow's milk allergy grow well and feel comfortable over 16 weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 0 Days to 8 Months
• Sex: All
• Sponsor: Nutricia Research (Industry-sponsored)
• Locations: 1 site (Kraków)
• Trial ID: NCT05618704 on ClinicalTrials.gov

What this trial studies

This clinical trial is an open-label, single-arm intervention designed to assess the growth, safety, and gastrointestinal tolerance of a hydrolyzed protein infant formula in infants diagnosed with cow's milk allergy. Over a 16-week period, participants will receive the formula while their growth parameters and allergy-related symptoms are monitored. The study aims to demonstrate that the formula supports adequate growth and is well-tolerated by infants with this allergy.

Who should consider this trial

Good fit: Ideal candidates for this study are infants under 8 months of age who have a clinical diagnosis of cow's milk allergy.

Not a fit: Patients who are not diagnosed with cow's milk allergy or are older than 8 months may not receive any benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective nutritional option for infants with cow's milk allergy, promoting healthy growth and development.

How similar studies have performed: Other studies have shown positive outcomes with hydrolyzed protein formulas in managing cow's milk allergy, indicating that this approach is supported by existing evidence.

Eligibility criteria

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.

Where this trial is running

Kraków

• Promed Medical Centre — Kraków, Poland (Recruiting)

Study contacts

• Study coordinator: Danone Nutricia Research

Conditions Cow Milk Allergy