NCT06633250 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.
| NCT ID | NCT06633250 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Société des Produits Nestlé (SPN) |
| Condition | Cow Milk Protein Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2024-10-25 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2024-10-25 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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 u
Frequently Asked Questions
Who can join the NCT06633250 clinical trial?
This trial is open to participants of all sexes, up to 8 Months, studying Cow Milk Protein Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06633250 currently recruiting?
Yes, NCT06633250 is actively recruiting participants. Visit ClinicalTrials.gov or contact Société des Produits Nestlé (SPN) to inquire about joining.
Where is the NCT06633250 trial being conducted?
This trial is being conducted at Berlin, Germany, Naples, Italy, Parma, Italy, Pisa, Italy and 1 additional location.
Who is sponsoring the NCT06633250 clinical trial?
NCT06633250 is sponsored by Société des Produits Nestlé (SPN). The trial plans to enroll 104 participants.