Cows Milk AllergyNCT05046418
Synbiotics Cohort Study
An observational study of Cows Milk Allergy, run by Nutricia UK Ltd at 1 site in United Kingdom.
Trial summary
Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics. Read more about this study
- Who is it for?
- Ages 0 to 13 months
- Conditions the study is for
- Cows Milk Allergy
- What is being tested?
- Hypoallergenic formula containing synbiotics
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 13 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- Cows Milk Allergy
- Being tested
- Hypoallergenic formula containing synbiotics
- Keywords
- synbiotics, paediatrics, gut microbiome
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoallergenic formula containing synbioticsOther
An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hypoallergenic formula containing synbiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare use
Data on the changes in healthcare use will be collected from medical records
Measured: 6 months
Secondary outcomes (1)
Clinical impact and acceptability
Clinical outcomes related to CMA and parent/carer and infant acceptability will be assessed
Measured: 12 months post initiation of hypoallergenic formula containing synbiotics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start5 Sep 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cows Milk AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Nutricia UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046418
- Sponsor's protocol ID
- HAFSYN21
- Status last verified
- Feb 2025
- First submitted
- 6 Sep 2021
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Cohort Study Investigating the Clinical Impact of Hypoallergenic Formulae With Synbiotics in Infants With Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT05046418
- Acronym / sponsor ID
- HAFSYN21
- Conditions
- Cows Milk Allergy
- Keywords
- synbiotics, paediatrics, gut microbiome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoallergenic formula containing synbiotics | – | Other: Hypoallergenic formula containing synbioticsInfants (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. |
Who may qualify
- Ages
- 0 to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoallergenic formula containing synbioticsAn extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics. | Other | Hypoallergenic formula containing synbiotics |
Primary outcome
Healthcare use
Time frame: 6 months
Data on the changes in healthcare use will be collected from medical records
1 secondary outcome
Clinical impact and acceptability
Time frame: 12 months post initiation of hypoallergenic formula containing synbiotics
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Nutricia UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cows Milk Allergy, run by Nutricia UK Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare use (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.