Synbiotic Extensively Hydrolysed Feed Study
- Conditions
- Cow Milk Allergy
- Interventions
- Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics
- Registration Number
- NCT03874104
- Lead Sponsor
- Nutricia UK Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- "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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study product Extensively Hydrolysed Formula containing Pre- & Probiotics Extensively Hydrolysed Formula containing Pre- and Probiotics
- Primary Outcome Measures
Name Time Method Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire 31 days Gastro-intestinal tolerance will be recorded by the parent on Baseline Days 1-3 (where this period is undertaken by the patient) and on Intervention Days 1, 2, 3, 7, 14, 21, 26, 27, and 28. Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, to be completed by the parents/carer
- Secondary Outcome Measures
Name Time Method Nutrient intake 31 days Nutrient intake, including the intake of all nutrition provided (including the study product, any other enteral tube feeding, foods, drinks etc.) will be recorded via a 24hr dietary recall, conducted by the Dietitian at the Baseline Visit and at the End of Study Visit.
Parent-reported Atopic Symptoms 31 days Recorded via visual analogue scales at baseline and at the end of each week. Parents will record on a 100mm line the severity of a number of common atopic symtpoms, with the scale running from "not at all/none" at 0mm and "as bad as possible/
Food Allergy QOL - Parental burden questionnaire 31 days Measured at baseline and at the end of study via a Food Allergy QOL - Parental Burden Questionnaire
Atopic dermatitis severity 31 days Measured via Patient Orientated SCORing Atopic Dermatitis (PO-SCORAD) tool at Baseline, Intervention Day 7 and the final dat of the study
Change in weight 31 days Weight will be measured at the start and end of the study in kg
Safety (Adverse Events) 31 days Adverse events captured throughout entire study
Change in length (cm) 31 days Length will be measured at the start and end of the study
Formula acceptability: Likert-style questionnaire 31 days Feed acceptability will be assessed on Baseline Day 3 (for current feed, where applicable) and on the final day of the intervention period (Intervention day 28) via a Likert-style questionnaire
Compliance 31 days Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received. The amount prescribed by the Dietitian will be recorded at the start of the study, and any changes to this prescription also noted. During the baseline period (where this is undertaken) the compliance of the patient's usual feed will be assessed.
Change in head circumference (cm) 31 days Head circumference will be measured at the start and end of the study
Trial Locations
- Locations (8)
Brighton and Sussex University Hospital NHS Foundation Trust
🇬🇧Brighton, United Kingdom
West Hertfordshire NHS Foundation Trust
🇬🇧Watford, United Kingdom
Ashford and St Peter's Hospital NHS Foundation Trust
🇬🇧Chertsey, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
🇬🇧Guildford, United Kingdom
University Hospitals Bristol NHS Foundation Trust
🇬🇧Bristol, United Kingdom
The Rotherham NHS Foundation Trust
🇬🇧Rotherham, United Kingdom
university Hospitals Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom