Clinical trial NCT06288503: Hydrolysed Rice Formula Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cow's Milk Protein Allergy
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 86
Sex: ALL
Minimum age (years): 0
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Growth
timeFrame: Baseline to three months
Secondary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Baseline to three months
measure: Stool frequency and consistency
timeFrame: Baseline to three months
measure: Study Product Intake
timeFrame: Baseline to three months
measure: Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD)
timeFrame: Baseline to three months
measure: Patient Reported Atopic Symptoms
timeFrame: Baseline to three months
measure: Cow's Milk Related Symptom Score
timeFrame: Baseline to three months
measure: Food Allergy Quality of Life-Parental Burden (FAQL-PB)
timeFrame: Baseline to three months
measure: Acceptability of the Study Formula
timeFrame: Baseline to three months
measure: Nutrient Intake (Energy, Protein, Micronutrients)
timeFrame: Baseline to three months
measure: Dietetic Goal
timeFrame: Baseline to three months
measure: Overall Safety
timeFrame: Through study completion, an average of three months
Other outcomes:
Locations:
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal NHS Trust
state: Gloucestershire
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: Somerset
Study officials:
References: