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Synbiotics Cohort Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 0 Months - 13 Months
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nutricia UK Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Nutricia UK
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Active, not recruiting
Countries United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Cows Milk Allergy
Additional Details

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

Arms & Interventions


: 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Adam Practice, Poole, United Kingdom



Adam Practice

Poole, ,

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