Synbiotics Cohort Study

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05046418

Enrollment

Registered

2021-09-16

Start date

2021-09-05

Completion date

2024-12-31

Last updated

2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cows Milk Allergy

Keywords

synbiotics, paediatrics, gut microbiome

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

Interventions

OTHERHypoallergenic formula containing synbiotics

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Months to 13 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Healthcare use	6 months	Data on the changes in healthcare use will be collected from medical records

Secondary

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026