Synbiotic Extensively Hydrolysed Feed Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cow Milk Allergy

Intervention / Treatment
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* Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 13 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study product<br>Extensively Hydrolysed Formula containing Pre- and Probiotics | Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics<br>* Extensively Hydrolysed Formula containing Pre- and Probiotics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire | 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 | 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | 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. | 31 days | 
| Parent-reported Atopic Symptoms | 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/ | 31 days | 
| Food Allergy QOL - Parental burden questionnaire | Measured at baseline and at the end of study via a Food Allergy QOL - Parental Burden Questionnaire | 31 days | 
| Formula acceptability: Likert-style questionnaire | 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 | 31 days | 
| Nutrient intake | 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. | 31 days | 
| Atopic dermatitis severity | Measured via Patient Orientated SCORing Atopic Dermatitis (PO-SCORAD) tool at Baseline, Intervention Day 7 and the final dat of the study | 31 days | 
| Change in weight | Weight will be measured at the start and end of the study in kg | 31 days | 
| Safety (Adverse Events) | Adverse events captured throughout entire study | 31 days | 
| Change in length (cm) | Length will be measured at the start and end of the study | 31 days | 
| Change in head circumference (cm) | Head circumference will be measured at the start and end of the study | 31 days |