Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
10 participants
OBSERVATIONAL
2021-09-05
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Synbiotic Extensively Hydrolysed Feed Study
NCT03874104
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy
NCT03062995
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy
NCT03067714
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
NCT01181297
Hypoallergenicity of a Hydrolyzed Protein Infant Formula
NCT05731206
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Hypoallergenic formula containing synbiotics
An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hypoallergenic formula containing synbiotics
An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
0 Months
13 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nutricia UK Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Nutricia UK
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Adam Practice
Poole, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HAFSYN21
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.