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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting
• Azienda Ospedaliera Universitaria Federico II
  Naples, Italy Recruiting
• Azienda Ospedaliero Universitaria di Parma
  Parma, Italy Recruiting
• AO Ordine Mauriziano
  Turin, Italy Recruiting
• Poliklinika Ginekologiczno-Położnicza Arciszewscy
  Bialystok, Poland Recruiting
• Centrum Medyczne Pratia
  Bydgoszcz, Poland Recruiting

Study contacts

• Study coordinator: Anthony de COZAR
• Email: anthony.decozar@rd.nestle.com
• Phone: +41762627426

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Introducing heated cow's milk to help children with milk allergies develop tolerance

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.