Remote monitoring of patients with small intestinal bacterial overgrowth, IBS and food intolerances

An estimated 13 million people in the UK suffer with irritable bowel syndrome (IBS), a digestive problem that can have a profound impact on quality of life. It is further estimated that as many as 80% of these (up to 10.8M patients) have small intestinal bacterial overgrowth (SIBO) and that an even larger number of people in the UK suffer from food intolerances.

Breath testing is commonly used as part of the diagnosis of SIBO. However, access to breath services throughout the NHS is limited. In particular, in this case Dr Munuswamy of the Mid and South Essex NHS Foundation Trust, was seeking to increase accessibility of breath testing for his patients. This need was especially highlighted during the COVID-19 pandemic.

Situation

COVID-19 has resulted in a significant backlog of patients awaiting elective procedures, such as breath testing for SIBO. However, clinical facilities offering breath testing services are not widespread in the UK, making it challenging for the patient to gain access. Moreover, traditional hospital-based breath testing is limited by the availability of resources, such as trained personnel and space, rendering it difficult to perform at scale.

Aspiration

To enable the remote monitoring of common gut disorders at scale, across the UK.

For this to be achievable, the testing must be performed in the home, under the guidance of the clinician. Being able to record other key factors, such as symptoms, meals, and stool form, would also be highly advantageous. This approach could improve the standard of care, promote patient activation, and reduce the burden on existing services.

Solution and impact

Dr Munuswamy worked with a medical device company, FoodMarble, which offers an app-connected breath test device to enable patients to perform testing at-home. The patients can also record other relevant data, including symptoms experienced during and after testing. The data is available in real time and sent securely to their doctor for review on a web-based, clinical dashboard.

Benefits of using the FoodMarble platform include:

  • Scale - giving the patient access to their own device for at-home testing, removes the limitations on the number of patients that can be treated at a time
  • Cost - the price per device is lower than currently available mail-in, at-home test kits (£180-£450). The FoodMarble platform enables the patient to perform multiple tests, significantly reducing the cost per test. The patient can also benefit from the app software (such as, symptom, stool, stress/sleep and meal tracking) for no additional cost
  • Time - when comparing to clinical sites with their own bench-top equipment, the traditional on-site breath test is 3 hours long and requires device and patient set-up, device operation, compilation of measurements, and interpretation of results. For this new approach, the patient is guided through the process by the app in their home and the results are compiled in real time. The results are then sent to the clinical staff for review on a web-based dashboard. The required staff input is estimated to have been reduced by more than 90%.
  • Patients - reduction in travel time and cost (in this case estimated as 140 minutes, £41). Increased flexibility to schedule the testing whenever it is convenient, which reduces time off work and/or childcare issues
  • NHS staff - reduction in total staff time for setup, testing and analysis, from 4 hours to 30 minutes
  • Health economy - the platform facilitates the remote monitoring of patients, which leads to a reduction in no-show appointments. Missed appointments cost the NHS almost £1bn in 2017. Remote patient testing also reduces the burden on in-hospital clinic appointments

Functionality

  • Each patient has their own device, which is connected to a smartphone app
  • The app is downloaded from the Apple App Store or Google Play Store
  • The clinician or admin staff member adds the patient on the web-based dashboard. The patient then receives an email containing the privacy policy. Each patient must agree to this before finalising their account set-up. They will also provide postage details for the device and substrate(s), which will be sent directly to the patient
  • All data logged in the app (breath, symptoms, meals, stool, sleep, stress), is transmitted and stored securely in a cloud-based server and can be accessed by the clinician in real time through the clinical dashboard
  • Once a patient has completed testing, an email notification is sent to the referring clinician to review the data

Capabilities

The FoodMarble device and app can:

  • provide at-home breath testing services
  • be used multiple times using different test substrates (such as, glucose, lactulose, fructose, lactose)
  • track symptoms during and after each test
  • track other clinical parameters, including meals, stool, sleep and stress
  • review data in real-time using a web-based clinical dashboard. Clinicians are notified by email with a link to test reports
  • download PDF reports on-demand for clinician review
  • be used by a clinician to support the diagnosis of SIBO
  • be used to help identify food triggers for IBS patients, under the guidance of a dietitian or gastroenterologist

The FoodMarble platform cannot however be used to diagnose IBS, which should instead be done using the Rome Criteria.

Scope

While the device and app could be used in the clinical environment, the full benefits are unlocked by use in the home, under the guidance of the clinician.

Key figures/quotes

“COVID-19 has underlined a need to adopt innovative tools to continue important patient testing. The FoodMarble platform allows the patient to test in the safety and comfort of their own home and the results are immediately available for review on the web-based clinical dashboard. This easy-to-use system has the potential to treat many more patients, while reducing the burden on the healthcare system. It improved patient engagement and participation in management of chronic symptoms. The user friendly digital interface led to greater patient and clinician satisfaction.”
Dr P. Munuswamy, consultant gastroenterologist, Mid and South Essex NHS Foundation Trust

Find out more

Read a pilot validation study of an at-home hydrogen breath test device

Read about the validity of a portable breath analyser for the assessment of lactose malabsorption

Key contact

Dr P. Munuswamy, consultant gastroenterologist, Mid and South Essex NHS Foundation Trust

pushpakaran.munuswamy@nhs.net

Claire Shortt, lead scientist, FoodMarble

claire@foodmarble.com