Hydrolysed Rice Formula Study
Recruiting
N/A
Interventional Study
Cow's Milk Protein Allergy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 0 Months – 13 Months
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 86 (estimated)
- Sponsor
- Nutricia UK Ltd · Industry
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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 pr…
Trial Locations
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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 CM…
Contacts