Synbiotics Cohort Study
Research type
Research Study
Full title
A prospective, observational, cohort study investigating the clinical impact of hypoallergenic formulae with synbiotics in infants with cow’s milk allergy
IRAS ID
300403
Contact name
Rebecca J Stratton
Contact email
Sponsor organisation
Nutricia Ltd
Clinicaltrials.gov Identifier
pending- application under review, ClinicalTrials.gov
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
Cow’s milk allergy (CMA) is one of the most common food allergies in infants. Management involves avoidance of intact cow’s milk protein, with suitable alternative foods or prescribable feeds used to ensure an adequate nutritional intake. Current guidelines recommend that formula fed infants with CMA should be prescribed a hypoallergenic formula. Recent research studies have demonstrated that having a healthy balance of different types of bacteria in the gut is also important in the management of CMA and pre- and probiotics can help to support this.
Compared to healthy breast fed infants, infants with CMA are more likely to experience infections and often require multiple visits to the GP. This presents a financial burden to the healthcare system. The increase in infections may be linked to the differences in the types of bacteria present in the gut of infants with CMA in comparison to healthy, breast-fed infants. Synbiotics are a combination of pre- and probiotics, which act to promote the growth of beneficial bacteria in the gut. Hypoallergenic formula containing synbiotics have been developed, which have been shown to increase the levels of beneficial bacteria in the gut of allergic infants, bringing it closer to that of healthy breast fed infants. There is also evidence that the addition of synbiotics may decrease the incidence of infections and healthcare use amongst infants with CMA.
This observational study will explore if these beneficial outcomes also occur in real-world settings in the U.K., outside of the controlled conditions in clinical trials. Fifty infants (<13 months) prescribed a hypoallergenic formula containing synbiotics (Aptamil Pepti Syneo or Neocate Syneo, Nutricia Ltd) for the management of CMA as part of usual care will be followed up over a period of 12 months. The study outcomes will be collected from medical records, parental report and healthcare professional assessment.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0249
Date of REC Opinion
16 Sep 2021
REC opinion
Further Information Favourable Opinion