Synbiotics Cohort Study

February 24, 2025 updated by: Nutricia UK Ltd

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Exclusively or partially formula fed infants with confirmed or suspected CMA who have been prescribed hypoallergenic formula containing synbiotics for the management of CMA as part of clinical care.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Hypoallergenic formula containing synbiotics
An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare use
Time Frame: 6 months
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
Time Frame: 12 months post initiation of hypoallergenic formula containing synbiotics
Clinical outcomes related to CMA and parent/carer and infant acceptability will be assessed
12 months post initiation of hypoallergenic formula containing synbiotics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia UK Ltd

Investigators

  • Study Director: Medical Director, Nutricia UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAFSYN21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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