Hydrolysed Rice Formula Study

Launched by NUTRICIA UK LTD · Feb 23, 2024

Keywords

ClinConnect Summary

The Hydrolysed Rice Formula Study is a clinical trial designed to see if a specially processed rice protein formula is just as effective as a well-known cow's milk protein formula for infants suspected of having a cow's milk protein allergy. This study will involve babies aged 0 to 13 months who show signs of this allergy. It will last for 28 days, followed by a two-month follow-up period, where researchers will check how well the babies grow, tolerate the formulas, and any allergic symptoms they may have. Parents will also share their experiences and how they feel about caring for their child during this time.

To participate, babies need to be between 0 and 13 months old and showing symptoms that suggest a cow's milk allergy. They should be able to get at least 30% of their energy from the study formula, and a parent or caregiver must give their written consent. Unfortunately, some babies won’t qualify, such as those with severe allergies, certain medical conditions, or those who have previously reacted to any ingredients in the study formulas. If your baby is eligible, you can expect regular check-ups and support throughout the study, helping to ensure their health and safety.

Gender

ALL

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