Cow Milk Protein Allergy
Conditions
Brief summary
The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).
Interventions
OTHERTest Formula
Hydrolyzed rice protein formula
OTHERControl Formula
Commercially available extensively hydrolyzed cow's milk formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Months
Healthy volunteers
No
Inclusion criteria
1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable) 2. Infant gestational age ≥ 37 completed weeks 3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg 4. Singleton birth 5. Infant age ≤ 8 months 6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk 7. Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below: 1. Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria/angioedema or vomiting, bloody streaks in stool, or respiratory symptoms 2. For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present 8. Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study 9. Infant's parent(s)/LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol
Exclusion criteria
1. History of intolerance to eHF formula 2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria) 3. Major gastrointestinal disease / abnormalities (other than CMPA) 4. Known or suspected lactose intolerance or malabsorption 5. Known or suspected soy allergy 6. Glucose-galactose malabsorption 7. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome). 8. Immunodeficiency 9. Persistent wheeze or chronic respiratory disease 10. Severe uncontrolled eczema 11. History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment 12. Weight-for-age value \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment 13. Height-for-age \< -2 or \> 2 standard deviations from the WHO Child Growth Standards median at enrollment 14. Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study 15. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight-for-age z-score at 4 months post-enrollment | From enrollment to 4 months post-enrollment | Weight measured in g and expressed in z scores according to the World Health Organization (WHO) Child Growth Standards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Monthly from enrollment to 4 months post-enrollment | Weight (g and z-scores) |
| Length | Monthly from enrollment to 4 months post-enrollment | Length (cm and z-scores) |
| Head circumference | At enrollmentn and 4 months post-enrollment | Head circumference (cm and z-scores) |
| Tibia lenght | At enrollmentn and 4 months post-enrollment | Tibia (cm) |
| Femur lenght | At enrollmentn and 4 months post-enrollment | Femur (cm) |
| Gastrointestinal Symptoms | Monthly from enrollment to 4 months post-enrollment, and 7 days after enrollment | The Infant Gastrointestinal Symptom Questionnaire (IGSQ) will be used to assess GI tolerance. The IGSQ is a validated instrument that includes 13 questions in 5 domains (stooling, spitting-up/vomiting, crying, fussiness, and flatulence) and total scores range from 13 (best) to 65 (worst) for overall GI symptom burden. |
| Stool frequency and consistency | At enrollment | A retrospective 1-day stool record including the Brussels Infant and Toddler Stool Scale will be used. |
| Cow's Milk-related Allergy Symptom | Monthly from enrollment to 4 months post-enrollment | The Cow's Milk-related Symptom Score (CoMiSS) will be used to assess symptoms related to CMPA. The CoMiSS questionnaire contains 6 items and generates a score based on gastrointestinal, dermatological, respiratory, and general symptoms (total score range 0-33), which may be associated with CMPA . |
| Food Allergy Quality of Life | At enrollment and 4 months post-enrollment | The Food Allergy Quality of Life Questionnaire (FAQLQ-PF) will be used. It is a validated instrument with 30 items in 3 domains (emotional impact, food-related anxiety, dietary and social restrictions). |
| Parental self-efficacy in managing food allergy | At enrollment and 4 months post-enrollment | Parental self-efficacy in managing their child's food allergy will be assessed using the Food Allergy Self-Efficacy Scale for Parents (FASE-P). The FASE-P is a validated instrument with 21 items. |
| Parent-reported infant health-related quality of life | At enrollment and 4 months post-enrollment | Parent-reported infant health-related quality of life will be assessed using the Infant and Toddler Quality of Life Questionnaire - Short Form (ITQOL-SF47). The ITQOL-SF47 is a validated instrument with 47 items. |
| Complementary food intake | At enrollment, 2 months post-enrollment and 4 months post-enrollment | Total energy and macronutrient intake calculated from food recalls / diaries. |
| Formula compliance | Monthly from enrollment to 4 months post-enrollment | A questionnaire will be used to assess formula compliance. |
| Formula liking | 4 months post-enrollment | A questionnaire will be used to assess formula liking. |
| Safety - Occurence of AE | From enrollment to 4 months post-enrollment | Adverse Events will be collected. |
Countries
Germany, Italy, Poland
Contacts
Primary ContactAnthony de COZAR
Outcome results
None listed