Hydrolysed Rice Formula Study

Nutricia UK Ltd86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cow's Milk Protein Allergy

Interventions

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.

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 13 Months

Medical Language ↔ Plain English

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

Locations (2)

Gloucestershire Royal NHS Trust

Gloucester, Gloucestershire, United Kingdom

RECRUITING

Bristol Royal Hospital for Children

Bristol, Somerset, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Isabel Evans, MSc

CONTACT

07385000738 Isabel.EVANS@danone.com

Gary P Hubbard, PhD

CONTACT

07738024720 gary.hubbard@nutricia.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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