An interventional study of Test Formula and Control Formula in Cow Milk Protein Allergy, sponsored by Société des Produits Nestlé (SPN). Recruiting at 19 sites in 3 countries. Open to participants aged Up to 8 Months. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Other
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).
Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:
Exclusion Criteria:
Hydrolyzed rice protein formula
Other: Test Formula
Commercially available extensively hydrolyzed cow's milk formula
Other: Control Formula
Hydrolyzed rice protein formula
Commercially available extensively hydrolyzed cow's milk formula
Weight-for-age z-score at 4 months post-enrollment
Weight measured in g and expressed in z scores according to the World Health Organization (WHO) Child Growth Standards.
Time frame: From enrollment to 4 months post-enrollment
Weight
Weight (g and z-scores)
Time frame: Monthly from enrollment to 4 months post-enrollment
Length
Length (cm and z-scores)
Time frame: Monthly from enrollment to 4 months post-enrollment
Head circumference
Head circumference (cm and z-scores)
Time frame: At enrollmentn and 4 months post-enrollment
Tibia lenght
Tibia (cm)
Time frame: At enrollmentn and 4 months post-enrollment
Femur lenght
Femur (cm)
Time frame: At enrollmentn and 4 months post-enrollment
Gastrointestinal Symptoms
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.
Time frame: Monthly from enrollment to 4 months post-enrollment, and 7 days after enrollment
Gastrointestinal Symptoms
A daily GI tolerance questionnaire will be used.
Time frame: First 7 days post enrollment
Stool frequency and consistency
A retrospective 1-day stool record including the Brussels Infant and Toddler Stool Scale will be used.
Time frame: At enrollment
Stool frequency and consistency
A 3-day stool diary including the Brussels Infant and Toddler Stool Scale will be used.
Time frame: 2 months and 4 months post-enrollment
Cow's Milk-related Allergy Symptom
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 .
Time frame: Monthly from enrollment to 4 months post-enrollment
Food Allergy Quality of Life
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).
Time frame: At enrollment and 4 months post-enrollment
Parental self-efficacy in managing food allergy
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.
Time frame: At enrollment and 4 months post-enrollment
Parent-reported infant health-related quality of life
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.
Time frame: At enrollment and 4 months post-enrollment
Complementary food intake
Total energy and macronutrient intake calculated from food recalls / diaries.
Time frame: At enrollment, 2 months post-enrollment and 4 months post-enrollment
Formula compliance
A questionnaire will be used to assess formula compliance.
Time frame: Monthly from enrollment to 4 months post-enrollment
Formula liking
A questionnaire will be used to assess formula liking.
Time frame: 4 months post-enrollment
Safety - Occurence of AE
Adverse Events will be collected.
Time frame: From enrollment to 4 months post-enrollment
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Société des Produits Nestlé (SPN)