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Recruiting NCT06288503

Hydrolysed Rice Formula Study

No phase Interventional Cow's Milk Protein Allergy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrolysed Rice Protein Formula, Cow's Milk Based Extensively Hydrolysed Formula.
Who it may be relevant to
Registry conditions: Cow's Milk Protein Allergy. Basic parameters: 0 months — 13 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Interventions

  • Other Hydrolysed Rice Protein Formula
    Infants randomised onto this arm will be taking the hydrolysed rice protein formula, with a minimum prescription of 30% of their energy requirements.
  • Other Cow's Milk Based Extensively Hydrolysed Formula
    Infants randomised onto this arm will be taking the control product, with a minimum prescription of 30% of their energy requirements.

Primary outcome measures

  • Growth [Time frame: Baseline to three months]
Secondary outcome measures (11)
  • Gastrointestinal Tolerance [Time frame: Baseline to three months]
  • Stool frequency and consistency [Time frame: Baseline to three months]
  • Study Product Intake [Time frame: Baseline to three months]
  • Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD) [Time frame: Baseline to three months]
  • Patient Reported Atopic Symptoms [Time frame: Baseline to three months]
  • Cow's Milk Related Symptom Score [Time frame: Baseline to three months]
  • Food Allergy Quality of Life-Parental Burden (FAQL-PB) [Time frame: Baseline to three months]
  • Acceptability of the Study Formula [Time frame: Baseline to three months]
  • Nutrient Intake (Energy, Protein, Micronutrients) [Time frame: Baseline to three months]
  • Dietetic Goal [Time frame: Baseline to three months]
  • Overall Safety [Time frame: Through study completion, an average of three months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United Kingdom · 2 centers
  • Gloucestershire Royal NHS Trust — Gloucester
  • Bristol Royal Hospital for Children — Bristol

Identifiers

NCT: NCT06288503 · HRF2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗