Hydrolysed Rice Formula Study
ConditionCow's Milk Protein Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-13
SponsorNutricia UK Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrolysed Rice Protein Formula
Other interventionInfants 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 Formula
Other interventionInfants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov