Clinical trial NCT03874104: Synbiotic Extensively Hydrolysed Feed Study
Official title: An Evaluation of the Tolerance and Acceptability of a Whey-based Extensively Hydrolysed Feed With Pre- and Probiotics, for the Dietary Management of Cows' Milk Allergy in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow Milk Allergy
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 35
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility 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

Primary outcomes:
measure: Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire
timeFrame: 31 days
Secondary outcomes:
measure: Compliance
timeFrame: 31 days
measure: Parent-reported Atopic Symptoms
timeFrame: 31 days
measure: Food Allergy QOL - Parental burden questionnaire
timeFrame: 31 days
measure: Formula acceptability: Likert-style questionnaire
timeFrame: 31 days
measure: Nutrient intake
timeFrame: 31 days
measure: Atopic dermatitis severity
timeFrame: 31 days
measure: Change in weight
timeFrame: 31 days
measure: Safety (Adverse Events)
timeFrame: 31 days
measure: Change in length (cm)
timeFrame: 31 days
measure: Change in head circumference (cm)
timeFrame: 31 days
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospital NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Chertsey
country: United Kingdom
facility: Ashford and St Peter's Hospital NHS Foundation Trust
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Rotherham
country: United Kingdom
facility: The Rotherham NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: university Hospitals Southampton NHS Foundation Trust
city: Watford
country: United Kingdom
facility: West Hertfordshire NHS Foundation Trust
Study officials:
References: