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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Hydrolysed rice protein formula |
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| Control | Active Comparator | Cow's milk based extensively hydrolysed formula |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolysed Rice Protein Formula | Other | Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabel Evans, MSc | Contact | 07385000738 | Isabel.EVANS@danone.com | |
| Gary P Hubbard, PhD | Contact | 07738024720 | gary.hubbard@nutricia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gloucestershire Royal NHS Trust | Recruiting | Gloucester | Gloucestershire | GL1 3NN | United Kingdom |
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| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Cow's Milk Based Extensively Hydrolysed Formula | Other | Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements. |
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| 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. | 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. | 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. | 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. | 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. | 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). | 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) | 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. | 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). | Baseline to three months |
| Overall Safety | All adverse events will be recorded throughout the study. | Through study completion, an average of three months |
| Bristol Royal Hospital for Children | Recruiting | Bristol | Somerset | BS16 1TA | United Kingdom |
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