Synbiotics Cohort Study

Nutricia UK Ltd10 enrolled

Overview

Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.

A range of clinical outcomes will be collected from the medical records and in-person assessment of 60 fully or partially formula fed infants (aged \<13 months) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of cow's milk allergy

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cows Milk Allergy

Interventions

Hypoallergenic formula containing synbioticsOTHER

An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 13 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Aged \<13 months * Confirmed or suspected CMA- based on healthcare professional (HCP) judgement * At baseline, parent(s) must already be exclusively or partially formula feeding their child (with a hypoallergenic or non-hypoallergenic formula) or have already made the decision to start exclusively or partially formula feeding * Recently prescribed a hypoallergenic formula containing synbiotics Exclusion Criteria: * Exclusively breastfed infants * Primary lactose intolerance * Enterally fed infants * Premature infants (born \<37 weeks) with a corrected age of less than 1 month * Infants with contraindications to the use of hyopallergenic formula containing synbiotics * Major hepatic or renal dysfunction * Investigator concern around the ability of family to comply with protocol and requirements of study

Locations (1)

Adam Practice

Poole, United Kingdom

Outcomes

Primary Outcomes

Healthcare use

Data on the changes in healthcare use will be collected from medical records

Time frame: 6 months

Secondary Outcomes

Clinical impact and acceptability

Clinical outcomes related to CMA and parent/carer and infant acceptability will be assessed

Time frame: 12 months post initiation of hypoallergenic formula containing synbiotics

Data from ClinicalTrials.gov

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