Cow's Milk Protein AllergyNCT06288503
Hydrolysed Rice Formula Study
A study testing Hydrolysed Rice Protein Formula and Cow's Milk Based Extensively Hydrolysed Formula in people with Cow's Milk Protein Allergy, run by Nutricia UK Ltd at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 13 months
- Conditions the study is for
- Cow's Milk Protein Allergy
- What is being tested?
- Hydrolysed Rice Protein Formula and Cow's Milk Based Extensively Hydrolysed Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Feb 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 13 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Bristol Royal Hospital for Children
Bristol, Somerset, BS16 1TA
Sarah Trace, 0117 3428802, sarah.trace@uhbw.nhs.uk
- Recruiting
Gloucestershire Royal NHS Trust
Gloucester, Gloucestershire, GL1 3NN
Victoria Bittle, 0300 422 5506, v.bittle@nhs.net
About this study
Official title: 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 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.
- Conditions
- Cow's Milk Protein Allergy
- Being tested
- Hydrolysed Rice Protein Formula, Cow's Milk Based Extensively Hydrolysed Formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolysed Rice Protein FormulaOther
Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.
Cow's Milk Based Extensively Hydrolysed FormulaOther
Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Hydrolysed rice protein formula Receives: Other: Hydrolysed Rice Protein Formula |
| Control | Active comparator | Cow's milk based extensively hydrolysed formula Receives: Other: Cow's Milk Based Extensively Hydrolysed Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
At Baseline (Day 1), End of Intervention (Day 31), and Follow-Up (Day 87) assessments, length and head circumference will be measured using standard measures to the nearest 0.1cm. Body weight (kg) will also be measured, where possible, by the investigating Dietitian/relevant HCP using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. These measures will be used to calculate z-scores (i.e., weight-for-length, weight, length, and head circumference; based on UK-WHO 2006 growth reference data for children 0-4 years old) and plotted on growth charts for centile measurement.
Measured: Baseline to three months
Secondary outcomes (11)
Gastrointestinal Tolerance
Gastrointestinal tolerance will be recorded by the parent/carer at Baseline Assessment and Baseline Days 1-3, where this period is undertaken by the patient), during the Intervention Period on Days 10, 17, 24, and 29-31, and during the 2-month Follow-Up period on Days 85-87. Tolerance will be recorded using a standardised GI tolerance questionnaire.
Measured: Baseline to three months
Stool frequency and consistency
Stool frequency and consistency (Brussels Infant and Toddler Stool Scale) will be recorded by the parent/carer at Baseline on Days 1-3 (where applicable), as well as on during the Intervention Period on Days 10, 17, 24, and 29-31, and during the 2-month Follow-Up on Days 85-87.
Measured: Baseline to three months
Study Product Intake
Intake of study product will be assessed daily throughout the Baseline and Intervention Periods by the parent/carer by recording how much feed was consumed. During the 2-month Follow-Up, intake of study product will be assessed for 3 days (Days 84-87). The daily minimum target intake amount prescribed by the investigating Dietitian/relevant HCP will be recorded at the start of the study, and any changes to this prescription will be noted.
Measured: Baseline to three months
Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD)
A self-evaluation tool will be completed by the parent/carer on the day of the Baseline Assessment (Day 1), on Days 10 and 31 during the Intervention Period, and on Day 87 during the 2-month Follow-Up to give an indication of severity of atopic dermatitis (where present). This will involve tick box questions and a diagram of an infant for the parent/carer to highlight presence of dermatitis.
Measured: Baseline to three months
Patient Reported Atopic Symptoms
The parent/carer will be asked to indicate their perception of the presence and severity of several common atopic symptoms for their child (wheezing, itchy/watery eyes, crying frequency, sneezing/runny/blocked nose, sleep quality) via 100mm visual analogue scales, with 100mm indicating more severe symptoms. These will be recorded on at Baseline Assessment (Day 1), on Day 3, Days 10, 17, 24, and 31 during the Intervention Period, and on Day 87 during the Follow-Up Period.
Measured: Baseline to three months
Cow's Milk Related Symptom Score
Infants' stool pattern, the presence and intensity of crying and regurgitation, as well as skin and respiratory manifestations will be assessed via the CoMiSS™ tool by the investigating Dietitian/relevant HCP at the Baseline (Day 1), End of Intervention (Day 31), and Follow-Up (Day 87) Assessments. Total scores range from 0-33, with higher number indicating more severe symptoms of cow's milk allergy.
Measured: Baseline to three months
Food Allergy Quality of Life-Parental Burden (FAQL-PB)
Parental measures of QOL (related to their child's allergy) will be assessed via a standardised validated questionnaire on the day of the Baseline Assessment (Day 1), on the final day of the Intervention Period (Day 31), and at the end of the Follow-Up Period (Day 87).
Measured: Baseline to three months
Acceptability of the Study Formula
Feed acceptability (e.g., ease of use, liking) will be assessed at Baseline (Day 3, where applicable), during the Intervention Period on Days 10 and 31, and at the end of the Follow-Up period on Day 87, via a Likert-style questionnaire completed by the parent/carer (strongly disagree/disagree/don't know/agree/strongly agree)
Measured: Baseline to three months
Nutrient Intake (Energy, Protein, Micronutrients)
Nutrient intake, including intake of all nutrition provided (including the study product, any other enteral feeding, foods, drinks etc.) will be recorded via a 24hr dietary recall conducted by the investigating Dietitian/relevant HCP at the Baseline (Day 1), Day 10, End of Intervention (Day 31), and Follow-Up (Day 87) Assessments. Dietary data will be inputted by the study team into nutritional software to estimate energy and macro- and micronutrient intakes.
Measured: Baseline to three months
Dietetic Goal
A dietetic goal (e.g., improve tolerance, reduce atopic symptoms, maintain symptom control, maintain normal growth) will be set by the investigating Dietitian/relevant HCP at the Baseline Assessment (Day 1) for each infant. At the End of Intervention Assessment (Day 31), the investigating Dietitian/relevant HCP will assess and note if the dietetic goal was met (yes/no) and will set a dietetic goal for the Follow-Up Period. At the Follow-Up Assessment (Day 87), the investigating Dietitian/relevant HCP will assess and note if the dietetic goal was met (yes/no).
Measured: Baseline to three months
Overall Safety
All adverse events will be recorded throughout the study.
Measured: Through study completion, an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Feb 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk Protein AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288503
- Sponsor's protocol ID
- HRF2023
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06288503
- Acronym / sponsor ID
- HRF2023
- Conditions
- Cow's Milk Protein Allergy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Hydrolysed Rice Protein FormulaHydrolysed rice protein formula |
| Control | Active comparator | Other: Cow's Milk Based Extensively Hydrolysed FormulaCow's milk based extensively hydrolysed formula |
Who may qualify
- Ages
- 0 to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolysed Rice Protein FormulaInfants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements. | Other | Intervention |
| Cow's Milk Based Extensively Hydrolysed FormulaInfants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements. | Other | Control |
Primary outcome
Growth
Time frame: Baseline to three months
At Baseline (Day 1), End of Intervention (Day 31), and Follow-Up (Day 87) assessments, length and head circumference will be measured using standard measures to the nearest 0.1cm. Body weight (kg) will also be measured, where possible, by the investigating Dietitian/relevant HCP using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. These measures will be used to calculate z-scores (i.e., weight-for-length, weight, length, and head circumference; based on UK-WHO 2006 growth reference data for children 0-4 years old) and plotted on growth charts for centile measurement.
11 secondary outcomes
Gastrointestinal Tolerance
Time frame: Baseline to three months
Stool frequency and consistency
Time frame: Baseline to three months
Study Product Intake
Time frame: Baseline to three months
Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD)
Time frame: Baseline to three months
Patient Reported Atopic Symptoms
Time frame: Baseline to three months
Cow's Milk Related Symptom Score
Time frame: Baseline to three months
Food Allergy Quality of Life-Parental Burden (FAQL-PB)
Time frame: Baseline to three months
Acceptability of the Study Formula
Time frame: Baseline to three months
Nutrient Intake (Energy, Protein, Micronutrients)
Time frame: Baseline to three months
Dietetic Goal
Time frame: Baseline to three months
Overall Safety
Time frame: Through study completion, an average of three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Cow's Milk Protein Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
Not yet recruiting
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
Cow's Milk Protein Allergy (CMPA)
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
RecruitingPhase 4
Pasteurised Donor Human Milk Supplementation for Term Babies
Neonatal Hypoglycemia, Metabolic Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolysed Rice Protein Formula and Cow's Milk Based Extensively Hydrolysed Formula in people with Cow's Milk Protein Allergy, run by Nutricia UK Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel Evans, MSc (07385000738, Isabel.EVANS@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth (time frame: Baseline to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.