ClinicalTrials.gg
TerminatedNCT05046418Updated Feb 26, 2025

Synbiotics Cohort Study

An observational study in Cows Milk Allergy, sponsored by Nutricia UK Ltd. Terminated at 1 site in United Kingdom. Open to participants aged 0 Months to 13 Months. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Nutricia UK Ltd (part of Danone) · Observational

Why this study was terminated
Poor recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
0 Months to 13 Months
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Cows Milk Allergy

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Keywords

  • synbiotics
  • paediatrics
  • gut microbiome
03

In context

Milk Hypersensitivity

147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.

This study's enrollment of 10 is below the median of 102 across 45 observational studies indexed under Milk Hypersensitivity.

Browse Milk Hypersensitivity studies →

Lead sponsor

Nutricia UK Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 13 Months
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherHypoallergenic formula containing synbiotics

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

06

What researchers measure

Primary outcomes

  1. Healthcare use

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

    Time frame: 6 months

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Adam Practice
    Poole, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Dec 2024, 39 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2021
First posted
Sep 16, 2021
StartActual
Sep 5, 2021
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
Feb 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05046418
Lead sponsor
Nutricia UK Ltd
Responsible party
Sponsor
First posted
Sep 16, 2021
Start date
Sep 5, 2021
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Feb 26, 2025

Study contacts

Medical Director
study director · Nutricia UK

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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