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New treatment option for Cow's Milk Protein Allergy
Official title Hydrolysed Rice Formula Study
ClinicalTrials.gov ID: NCT06288503
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 13
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gloucester, Gloucestershire, United Kingdom
- Bristol, Somerset, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 months to 13 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gloucester, Gloucestershire, United Kingdom; Bristol, Somerset, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.