Hydrolysed Rice Formula Study

April 9, 2026 updated by: Nutricia UK Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Recruiting
        • Gloucestershire Royal NHS Trust
        • Contact:
    • Somerset
      • Bristol, Somerset, United Kingdom, BS16 1TA
        • Recruiting
        • Bristol Royal Hospital for Children
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Hydrolysed rice protein formula
Other: Hydrolysed Rice Protein Formula
Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.
Active Comparator: Control
Cow's milk based extensively hydrolysed formula
Other: Cow's Milk Based Extensively Hydrolysed Formula
Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal Tolerance
Time Frame: Baseline to three months
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.
Baseline to three months
Stool frequency and consistency
Time Frame: Baseline to three months
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.
Baseline to three months
Study Product Intake
Time Frame: Baseline to three months
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.
Baseline to three months
Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD)
Time Frame: Baseline to three months
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.
Baseline to three months
Patient Reported Atopic Symptoms
Time Frame: Baseline to three months
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.
Baseline to three months
Cow's Milk Related Symptom Score
Time Frame: Baseline to three months
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.
Baseline to three months
Food Allergy Quality of Life-Parental Burden (FAQL-PB)
Time Frame: Baseline to three months
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).
Baseline to three months
Acceptability of the Study Formula
Time Frame: Baseline to three months
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)
Baseline to three months
Nutrient Intake (Energy, Protein, Micronutrients)
Time Frame: Baseline to three months
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.
Baseline to three months
Dietetic Goal
Time Frame: Baseline to three months
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).
Baseline to three months
Overall Safety
Time Frame: Through study completion, an average of three months
All adverse events will be recorded throughout the study.
Through study completion, an average of three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia UK Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRF2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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