Synbiotic Extensively Hydrolysed Feed Study
Research type
Research Study
Full 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.
IRAS ID
234276
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia Ltd
Duration of Study in the UK
1 years, 7 months, 17 days
Research summary
The dietary management of Cows’ Milk Allergy (CMA) involves avoiding intact cows’ milk protein in the diet, whilst ensuring that an adequate nutritional intake is achieved with suitable alternative foods or prescribable feeds. Current guidelines state that for formula fed infants with mild to moderate CMA, an extensively hydrolysed formula (eHF) should be prescribed first line and foods containing cows’ milk protein should be avoided. There is now also considerable evidence that having a normal, healthy gut microbiota is important for the management and prognosis of allergic disease, including CMA, and that pre- and probiotics can help to improve an individual’s gut microbiota.
Aptamil Pepti Syneo is a whey-based eHF, intended for the dietary management of CMA in infants. Aptamil Pepti Syneo is based on an established and proven hypoallergenic eHF (Aptamil Pepti) which has been supplemented with both pre- and probiotics with a view to promoting a healthy gut microbiota.
This study of the tolerance and acceptability of Aptamil Pepti Syneo will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged <13 months) currently using or requiring an extensively hydrolysed feed 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 Aptamil Pepti Syneo 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 Aptamil Pepti Syneo for 4 weeks. The study is conducted for the Advisory Committee on Borderline Substances (ACBS) in the UK and will be set up according to ACBS requirements for acceptability studies.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1711
Date of REC Opinion
19 Oct 2017
REC opinion
Favourable Opinion