Hydrolyzed rice protein formula to support growth and tolerance in infants with cow's milk protein allergy

Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study

This trial will test whether a hydrolyzed rice protein-based infant formula helps babies with cow's milk protein allergy grow as well and tolerate feeding as well as a control formula.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: N/A to 8 Months
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (Industry-sponsored)
• Locations: 19 sites (Berlin and 18 other locations)
• Trial ID: NCT06633250 on ClinicalTrials.gov

What this trial studies

Term infants up to 8 months with suspected or confirmed cow's milk protein allergy who are fully formula-fed will receive either a hydrolyzed rice protein-based test formula or a control formula while remaining on a strict cow's milk elimination diet. The main goal is to show that growth on the test formula is not worse than growth on the control formula; gastrointestinal tolerance, health-related quality of life, and formula acceptability will also be recorded. Measurements include growth parameters and parent-reported tolerance and quality-of-life questionnaires collected during follow-up visits at participating pediatric centers. The trial is conducted at tertiary hospitals in Germany and Italy and is sponsored by a commercial formula manufacturer.

Who should consider this trial

Good fit: Term singleton infants aged ≤8 months who are fully formula-fed (no breast milk), have suspected or confirmed CMPA, are on a strict cow's milk elimination diet, and meet the listed birth weight and consent requirements.

Not a fit: Infants who are still breastfeeding, born preterm, have other serious medical conditions, or require amino-acid-based formulas for severe IgE-mediated allergy are unlikely to benefit from this formula.

Why it matters

Potential benefit: If successful, this formula could offer a well-tolerated, non-dairy option that supports normal growth in infants with cow's milk protein allergy.

How similar studies have performed: Previous smaller studies and clinical experience suggest hydrolyzed rice-based formulas can support growth and are tolerated by many infants with CMPA, but the evidence base is smaller than for extensively hydrolyzed cow's milk or amino-acid formulas.

Eligibility criteria

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

Where this trial is running

Berlin and 18 other locations

• Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
• Azienda Ospedaliera Universitaria Federico II — Naples, Italy (Recruiting)
• Azienda Ospedaliero Universitaria di Parma — Parma, Italy (Recruiting)
• AOUP Ospedale Santa Chiara — Pisa, Italy (Completed)
• Ospedale Pediatrico Bambino Gesu — Rome, Italy (Not_yet_recruiting)
• AO Ordine Mauriziano — Turin, Italy (Recruiting)
• Poliklinika Ginekologiczno-Położnicza Arciszewscy — Bialystok, Poland (Recruiting)
• Centrum Medyczne Pratia — Bydgoszcz, Poland (Recruiting)
• IN-VIVO Bydgoszcz — Bydgoszcz, Poland (Recruiting)
• Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny — Bydgoszcz, Poland (Recruiting)
• Vitamed Galaj i Cichomski — Bydgoszcz, Poland (Recruiting)
• BioMedical Centers — Janki, Poland (Recruiting)
• Centrum Medyczne Plejady — Krakow, Poland (Completed)
• Jagiellonian University Medical College — Krakow, Poland (Recruiting)
• Wojewodzki Szpital Specjalistyczny im. M. Kopernika — Lodz, Poland (Recruiting)
• ETG Lublin — Lublin, Poland (Recruiting)
• Korczowski Bartosz Gabinet Lekarski — Rzeszów, Poland (Recruiting)
• Alergo-Med Specjalistyczna Przychodnia Lekarska — Tarnów, Poland (Recruiting)
• University Hospital of Warsaw — Warsaw, Poland (Completed)

Study contacts

• Study coordinator: Anthony de COZAR

Conditions Cow Milk Protein Allergy