160 patients from Spain, Italy, Portugal, Belgium and the Netherlands have participated in an international clinical trial using the Cystic Fibrosis Application for personalising the nutrition of children with cystic fibrosis. On 14 December, the project experts presented the results during their final meeting.
The mobile app improves the quality of life of patients as it not only helps them to manage their food intake, it also optimises their pancreatic enzyme replacement therapy - most patients with cystic fibrosis follow this therapy to help their bodies digest food nutrients, as they often suffer from pancreatic insufficiency.
The dose of supplementary enzymes depends on the characteristics of food, and the needs of each patient. However, up to now, there was no scientific method available for doing this calculation. For this reason, patients had to do an approximate calculation themselves.
This is where the MyCyfAPP experts came in. They performed an in vitro food research, and now researchers are able to determine the optimal dose of supplementary enzymes for each food product.
According to project coordinator Dr. Carmen Ribes, this is a breakthrough: "For the first time, there is a scientific method to determine the optimal amount of Pancreatic Enzyme Replacement Therapy".
The conclusions of this research allowed the Consortium to develop a complex algorithm able to predict in real time the optimal pancreatic dose. The algorithm, implemented in a mobile app, gives the patients the opportunity to use a scientific-base method to calculate their optimal dose. Patients only need to introduce the food they are going to eat, and the application calculates the optimal amount of supplementary enzymes for that specific meal.
Success of the clinical trial
Along six months, 160 patients from 6 European Cystic Fibrosis Units have participated in the clinical trial of the app. Under the close supervision of their healthcare units, they have used the app on a daily basis to self-calculate their optimal dose.
Dr. Ribes: "The results of the clinical trial, that has just finished, have proved that the new calculation method is valid as patients have improved their wellbeing in each of the scales analysed. In fact, patients have significantly reduced their gastrointestinal symptoms and their worry to suffer pain or any other abdominal symptoms."
"On the other hand, the clinical trial has also confirmed that patients reached the average coefficient of fat absorption of 90%. This was one of the set goals of the project as this confirms that the dose suggested by the app is appropriate for absorbing the fat and nutrients of food."
Easy to use and increased independence
A mother of a child who participated in the clinical trial says: "When they explained the application to us, I thought it would be difficult. But it is actually very easy to use! It has satisfied our expectations as it has helped to balance our family diet, and has also helped us to adjust the doses of enzymes we give to our daughter".
Philine Affourtit, a dietician at Erasmus Medical Center in Rotterdam (the Netherlands) adds: "The mobile application is very useful for teenagers as it helps them to become independent because they can think for themselves about what they want to do and what they should take instead of asking their parents what they should take".
Project leaders confirmed that it is the project's commitment that patients can keep on using the app now the clinical trial has finished. In addition, the team is working to guarantee that other cystic fibrosis units of Europe and their patients can also access this new resource.
The MyCyFAPP project has been funded by the European Union under the Horizon 2020 framework. This programme has the goal of promoting research and innovation projects promoting industrial leadership in Europe reinforcing the excellence.
The European Commission considers MyCyFAPP a 'Star Project' as it is about to achieve its objectives and go beyond them in an exemplary way. The consortium comprises 12 companies and research institutions from 5 European countries and is being coordinated by the Instituto de Investigación Sanitaria La Fe (Valencia, Spain).