Synbiotics Cohort Study

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

Detailed Description
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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

Official Title
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A Prospective, Observational, Cohort Study Investigating the Clinical Impact of Hypoallergenic Formulae With Synbiotics in Infants With Cow's Milk Allergy

Conditions
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Cows Milk Allergy

Intervention / Treatment
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* Other: Hypoallergenic formula containing synbiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 13 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypoallergenic formula containing synbiotics<br>Infants (aged <13 months) with cow's milk allergy (CMA) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of CMA. | Other: Hypoallergenic formula containing synbiotics<br>* An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare use | Data on the changes in healthcare use will be collected from medical records | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical impact and acceptability | Clinical outcomes related to CMA and parent/carer and infant acceptability will be assessed | 12 months post initiation of hypoallergenic formula containing synbiotics | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synbiotics, paediatrics, gut microbiome