| NCT ID | NCT06288503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nutricia UK Ltd |
| Condition | Cow's Milk Protein Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-07 |
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 86 participants in total. It began in 2024-02-01 with a primary completion date of 2027-07.
⚠ 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
This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.
Eligibility Criteria
Inclusion Criteria: * Male or female * Aged 0-13 months * Presenting to primary or secondary care with symptoms/clinical history suggestive of CMA * Will receive at least 30% of energy requirements from the study formula * Written informed consent from parent/carer Exclusion Criteria: * Severe CMA (including anaphylaxis) and/or requiring an AAF * Faltering growth (based on NICE guidelines36 - Appendix 1) * Previous allergy to any study product ingredients (including whey hydrolysate and/or rice) * Primary lactose intolerance * Food Protein-Induced Enterocolitis Syndrome (FPIES) * Exclusively breast fed * Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes * Severe hepatic or renal insufficiency * Premature infants (born \<37 weeks) with a corrected age of \<4 weeks * Requirement for any parenteral nutrition * Participation in other clinical intervention studies within 1 month of recruitment * Concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06288503 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 13 Months, studying Cow's 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 NCT06288503 currently recruiting?
Yes, NCT06288503 is actively recruiting participants. Contact the research team at Isabel.EVANS@danone.com for enrollment information.
Where is the NCT06288503 trial being conducted?
This trial is being conducted at Gloucester, United Kingdom, Bristol, United Kingdom.
Who is sponsoring the NCT06288503 clinical trial?
NCT06288503 is sponsored by Nutricia UK Ltd. The trial plans to enroll 86 participants.