Clinical trial NCT05618704: Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow Milk Allergy
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2022-11-16
Enrollment: 69
Sex: ALL
Minimum age (years): 0
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm, open label, interventional, multi-centre study
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Adequate growth
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
measure: Growth
timeFrame: 16 weeks
measure: Cow's milk related symptoms
timeFrame: 16 weeks
measure: Gastrointestinal tolerance
timeFrame: 16 weeks
measure: Concentration of markers of mineral status in blood
timeFrame: 16 weeks
measure: Study product intake (ml/day) and complementary foods/drinks (food diary)
timeFrame: 3 days prior to the last visit
measure: Study product appreciation
timeFrame: 16 weeks
Locations:
city: Kraków
country: Poland
facility: Promed Medical Centre
Study officials:
References: