Status:
COMPLETED
Synbiotic Extensively Hydrolysed Feed Study
Lead Sponsor:
Nutricia UK Ltd
Conditions:
Cow Milk Allergy
Eligibility:
All Genders
Up to 13 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- "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
Key Trial Info
Start Date :
August 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03874104
Start Date
August 22 2018
End Date
July 31 2023
Last Update
November 27 2023
Active Locations (8)
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1
Brighton and Sussex University Hospital NHS Foundation Trust
Brighton, United Kingdom
2
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
3
Ashford and St Peter's Hospital NHS Foundation Trust
Chertsey, United Kingdom
4
Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom