Hydrolysed rice protein formula for infants with cow's milk allergy
A Double-blind, Randomised-controlled Trial Evaluating a Hydrolysed Rice Formula Compared to a Cow's Milk Protein-based Extensively Hydrolysed Formula in Infants With Cow's Milk Allergy
This study is testing if a new rice-based formula can safely help infants with cow's milk allergy grow and feel better compared to a standard formula made from cow's milk protein.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 0 Months to 13 Months |
| Sex | All |
| Sponsor | Nutricia UK Ltd Industry-sponsored |
| Locations | 2 sites (Gloucester, Gloucestershire and 1 other locations) |
| Trial ID | NCT06288503 on ClinicalTrials.gov |
What this trial studies
This non-inferiority study evaluates the effectiveness of a hydrolysed rice protein formula compared to a cow's milk protein-based extensively hydrolysed formula in infants aged 0-13 months who show symptoms of cow's milk allergy. The study employs a double-blind, randomised-controlled design over a 28-day intervention period, followed by a 2-month follow-up. Primary outcomes focus on growth, while secondary outcomes include gastrointestinal tolerance, allergic symptoms, parental quality of life, and safety. Participants will receive at least 30% of their energy requirements from the study formula.
Who should consider this trial
Good fit: Ideal candidates are infants aged 0-13 months presenting with symptoms suggestive of cow's milk allergy.
Not a fit: Patients with severe cow's milk allergy requiring amino acid-based formulas or those with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative formula for infants with cow's milk protein allergy, improving their nutritional intake and overall health.
How similar studies have performed: While similar studies have explored alternative formulas for cow's milk allergy, this specific approach using hydrolysed rice protein is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gloucester, Gloucestershire and 1 other locations
- Gloucestershire Royal NHS Trust — Gloucester, Gloucestershire, United Kingdom (Recruiting)
- Bristol Royal Hospital for Children — Bristol, Somerset, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Isabel Evans, MSc
- Email: Isabel.EVANS@danone.com
- Phone: 07385000738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.