FARE - Food Allergy Research & Education Logo

Synbiotic Extensively Hydrolysed Feed Study

Study Purpose

This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged <13 months) currently using or requiring an extensively hydrolysed formula for the dietary management of CMA. Patients already prescribed an eHF (or other appropriate feed for CMA) at time of recruitment will undertake a 3 day baseline period in which their current symptoms, compliance, GI tolerance and acceptability towards their current feed is assessed, before introducing the study product for a period of 4 weeks. Patients who are not on an eHF (or other appropriate feed for CMA) at baseline will forgo this 3 day baseline period and immediately introduce the study product for 4 weeks.

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 N/A - 13 Months
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Aged <13 months.
  • - Currently using or requiring an extensively hydrolysed formula for the dietary management of cows' milk allergy.
  • - Expected to receive at least 25% of their energy intake from the study feed.
  • - Already fed with infant formula or hypoallergenic formula (either partially or fully) - Written, informed consent from parent/carer.

Exclusion Criteria:

  • - "Severe" cows' milk allergy (clinically judged to require an amino acid formula) or any other contraindications to the use of an extensively hydrolysed formula.
  • - Exclusively breastfed infants.
  • - Primary lactose intolerance.
  • - History of poor tolerance to whey based EHFs.
  • - Immunocompromised infants.
  • - Premature infants (born <37 weeks) - Major hepatic or renal dysfunction.
  • - Requirement for any parenteral nutrition.
  • - Tube-fed via a post-pyloric route.
  • - Participation in other clinical intervention studies within 1 month of recruitment to this study.
- 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.

Principal Investigator Affiliation N/A
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.

Cow Milk Allergy
Arms & Interventions


Experimental: Study product

Extensively Hydrolysed Formula containing Pre- and Probiotics


Dietary Supplement: - Extensively Hydrolysed Formula containing Pre- & Probiotics

Extensively Hydrolysed Formula containing Pre- and Probiotics

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

Brighton, United Kingdom



Brighton and Sussex University Hospital NHS Foundation Trust

Brighton, ,

Bristol, United Kingdom



University Hospitals Bristol NHS Foundation Trust

Bristol, ,

Chertsey, United Kingdom



Ashford and St Peter's Hospital NHS Foundation Trust

Chertsey, ,

Guildford, United Kingdom



Royal Surrey County Hospital NHS Foundation Trust

Guildford, ,

London, United Kingdom



Guy's and St Thomas' NHS Foundation Trust

London, ,

The Rotherham NHS Foundation Trust, Rotherham, United Kingdom



The Rotherham NHS Foundation Trust

Rotherham, ,

Southampton, United Kingdom



university Hospitals Southampton NHS Foundation Trust

Southampton, ,

West Hertfordshire NHS Foundation Trust, Watford, United Kingdom



West Hertfordshire NHS Foundation Trust

Watford, ,

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.