An interventional study of Hydrolysed Rice Protein Formula and Cow's Milk Based Extensively Hydrolysed Formula in Cow's Milk Protein Allergy, sponsored by Nutricia UK Ltd. Recruiting at 2 sites in United Kingdom. Open to participants aged 0 Months to 13 Months. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Nutricia UK Ltd (part of Danone) · Not applicable, Interventional, and Treatment
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.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 86 is above the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Nutricia UK Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hydrolysed rice protein formula
Other: Hydrolysed Rice Protein Formula
Cow's milk based extensively hydrolysed formula
Other: Cow's Milk Based Extensively Hydrolysed Formula
Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.
Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.
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.
Time frame: Baseline to three months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: Baseline to three months
Overall Safety
All adverse events will be recorded throughout the study.
Time frame: Through study completion, an average of three months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Jul 2027, 41 months after the start.
Of 34 interventional studies with no phase under Milk Hypersensitivity, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 48. This study's planned 41 months is above that.
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