Synbiotics Cohort Study

Terminated

• Conditions: Cows Milk Allergy
• Interventions: Other: Hypoallergenic formula containing synbiotics

• Registration Number: NCT05046418
• Lead Sponsor: Nutricia UK Ltd

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2021-09-05
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypoallergenic formula containing synbiotics	Hypoallergenic formula containing synbiotics	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.

Primary Outcome Measures

Name	Time	Method
Healthcare use	6 months	Data on the changes in healthcare use will be collected from medical records

Secondary Outcome Measures

Name	Time	Method
Clinical impact and acceptability	12 months post initiation of hypoallergenic formula containing synbiotics	Clinical outcomes related to CMA and parent/carer and infant acceptability will be assessed

Trial Locations

Locations (1)

Adam Practice; 🇬🇧 Poole, United Kingdom