BPSU study - Food protein induced enterocolitis syndrome (FPIES)

This BPSU study investigates food protein induced enterocolitis syndrome (FPIES), a rare delayed type of food allergy which leads to repeated vomiting and other gastrointestinal symptoms up to several hours after a problem food (or baby formula) is eaten. There is very limited data on FPIES in the UK and this study is intended to improve our knowledge of the incidence, clinical presentation and management as well as improve awareness amongst paediatricians. This has the potential to benefit patients and families through quicker diagnosis and instigation of effective management of FPIES.

Lead investigators

Dr Gary Stiefel
Respiratory Office, Ward 28, Level 4, Windsor Building
Leicester Royal Infirmary
Infirmary Square
Leicester LE1 5WW
Email: gary.ghs.stiefel@uhl-tr.nhs.uk / gary.ghs.stiefel@nhs.net

Dr Mich Erlewyn-Lajeunesse
Southampton General Hospital
Tremona Road
Southampton SO16 6YD

About the study

FPIES is a rare but serious form of food allergy. It manifests in infancy as repetitive vomiting, diarrhoea and a systemic inflammatory response. In some children it may progress to dehydration and shock. It was first described about 30 years ago in the United States. Over the last decade increasing numbers of cases are being recognised by paediatricians in the UK. However, the condition is under recognised which can lead to misdiagnosis and delay in treatment. The most common foods causing FPIES are cow’s milk, soya and rice although many other causative foods have been described. Diagnosis is predominantly clinical, and management involves dietary exclusion and symptomatic treatment in cases of accidental ingestion.

There is very limited available data regarding the incidence and prognosis of this condition, and none from the UK. A single study in Israel showed a cumulative incidence of 0.34% of milk FPIES. Our clinical experience suggests that the UK incidence of this rare but important condition is much lower, but this may be due to under recognition by UK paediatricians. The Australian PSU has recently completed an FPIES survey and have recently published. They reported 230 cases in 29 months with an incidence of 15.4/100,000/year.

You can download the protocol card, including references, below.

Case definition

Any infant <24 months at time of initial FPIES reaction where there was a history of :

  1. Repeated episodes of vomiting presenting within 4 hours after eating, where 
  2. Removal of this food resulted in resolution of symptoms.

Excluding

  • Fever >38°C
  • Any cutaneous symptoms (urticaria, angioedema)
  • Respiratory features (difficulty in breathing/talking, swelling of tongue, tight throat/hoarse voice, wheeze and/or persistent cough)
  • Other causes such as confirmed sepsis, an acute abdomen, gastroenteritis or cyclical vomiting syndrome.

Reporting instructions

Please report any cases seen within the last month that meet the case definition (including cases seen in clinic).

Duration

January 2019 to January 2020 (13 months of surveillance)

Funding

The study is funded by Midlands Asthma and Allergy Research Association (MAARA).

Approval

The study has been approved by London - Stanmore Research Ethics Committee (reference: 18/LO/0972) and HRA Confidentiality Advisory Group (reference: 18/CAG/0113). Public Benefit & Privacy Panel, Scotland approval awaited.

Privacy information

University Hospitals of Leicester NHS Trust (UHL) is the sponsor and data controller for this research study - see UHL’s privacy notice. The Data Protection Officer, Saiful Choudhury at UHL can be contacted on 0116 258 6053.

The study team at UHL will use information from medical records for medical research. We will collect information about children with a new diagnosis of FPIES from the doctors who are looking after them. Doctors will not provide names and addresses to the study team but they will provide details like sex, ethnic group, date of birth, NHS/CHI number and partial postcodes (first 4 digits). Doctors will complete questionnaires using information from medical records. If you want access to the information in your child’s medical records, then you should contact your child’s NHS hospital or doctor. We cannot withdraw or remove personal information from the study as this would make the research invalid. After the study finishes, UHL will securely store information for 20 years, then anonymise or destroy it. Under the EU General Data Protection Regulation, the legal basis for processing this information is for the performance of a task carried out in the public interest. You can find out how the study uses personal information by contacting Dr Gary Stiefel (gary.ghs.stiefel@nhs.net).

If you wish to complain about the use of personal information, then you should contact the Information Commissioner's Office.

Support groups

Partners

BPSU | Leicester Children's Hospital | Southampton Children's Hospital | MMARA Midlands Asthma & Allergy Association | AllergyUK | FPIES UK