Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrolyzed protein infant formula | Experimental | All subjects will take the hydrolyzed protein infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolyzed protein infant formula | Dietary Supplement | The subjects will take the formula for 16 weeks |
|
| 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 |
Not provided
| 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 |
Inclusion Criteria:
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:
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.
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Promed Medical Centre | Krakow | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
single arm, open label, interventional, multi-centre study
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |