Salomé Pinho’s Team Leads a Clinical Study on Crohn’s Disease
A multidisciplinary team, led by i3S researcher Salomé Pinho, will move forward with a pioneering clinical study to explore how glycan supplementation can intercept the onset of the inflammatory process that characterises the transition to Crohn’s Disease. Patient recruitment has already begun at Hospital da Luz Lisboa, under the coordination of gastroenterologist Joana Torres, and the entire clinical study will be developed in collaboration with the pharmaceutical company Medinfar. The team hopes the results will shed new light on the role of glycans (complex sugars that coat the surface of intestinal cells) in controlling the intestinal inflammation that characterises Crohn’s Disease.
The study will focus specifically on patients with Crohn’s Disease who undergo surgery for the surgical removal of the inflamed segment of the intestine. In theory, these patients have their disease surgically removed. However, a significant portion of these patients may experience a relapse in the following ten years. In these situations, the first signs are detected by endoscopy in the first year after surgery, and all indications are that the processes leading to the relapse of inflammation are similar to those that lead to the onset of the disease. That is “it is believed that the same factors that contribute to the development of the disease in its initial stages will be the same ones that contribute to a relapse in the post-operative context” clarifies Salomé Pinho, leader of the i3S group “Immunology, Cancer & GlycoMedicine”, coordinator of the European project in which this clinical study is included, and affiliated professor at the Faculty of Medicine (FMUP) and the Abel Salazar Biomedical Sciences Institute (ICBAS) of the University of Porto.
It is at this stage, which mimics the transition from health to intestinal inflammation, that the team intends to intervene through the oral administration of a glycan in the form of a dietary supplement. Salomé Pinho explains “We have recent evidence from the group that demonstrates the existence of changes in the composition of glycans (in the glycosylation process) in a pre-clinical phase, where there are still no symptoms. This alteration seems to contribute to the triggering of intestinal inflammation, hence the relevance of repairing this defect at an early stage, anticipating the prevention of the inflammatory process’s onset.”
This study arises from the results obtained within the scope of the European GlycanTrigger project, led by Salomé Pinho, which also includes gastroenterologist Joana Torres of Hospital da Luz Lisboa, who is responsible for the coordination and implementation of the clinical study.
The patients will be followed for a period of six months after the surgical removal of the affected segment of the intestine. The objective of this study, explains Joana Torres, “is to study the impact of this glycan on the composition and function of the microbiome, and on the protection of the intestinal barrier composed of glycans on the mucosal surface (glycocalyx), thus acting on one of the potential primary mechanisms of the disease.”
“We will also try to understand the clinical impact of this glycan supplement on controlling the inflammatory response of the intestine in this health-to-disease transition phase,” adds Joana Revés, a gastroenterologist who is also part of the team that will accompany these patients.
The implementation of this clinical study, as well as its coordination, will be carried out by Hospital da Luz Lisboa, and expressions of interest from patients with Crohn's Disease to participate can be sent to the email: GlycanTrigger@hospitaldaluz.pt
Partnership between Science, Clinicians, and the Pharmaceutical Industry
This clinical study, as highlighted by the parties involved, is the result of a very important and desired partnership between science, clinical practice, and the pharmaceutical industry. Medinfar will be the industry partner that will provide the glycan supplement, following manufacturing best practices, with a view to the possible establishment of a new product for the promotion of intestinal health. Medinfar’s participation in this project, underlines Mariana Almeida, Medinfar’s Innovation Manager, “reflects our continuous commitment to Innovation and Development with the goal of finding solutions that can respond to the healthcare needs of the population.”
About Crohn’s Disease
Crohn’s disease is a chronic, immune-mediated inflammatory bowel disease that causes inflammation of the digestive and intestinal tract. Common symptoms include diarrhoea, abdominal pain, fatigue, and weight loss, among others. It can affect all age groups, but it is typically diagnosed in adolescents and young adults. In recent years, not only in Portugal but throughout the world, there has been a growing incidence of this pathology.
In many cases, the disease can be controlled, preventing flare-ups for long periods. However, it continues to be a disease with a huge impact on patients’ quality of life, with a significant proportion not responding to currently available treatments and requiring surgery, which highlights the importance of investigating new paradigms, particularly in the areas of early diagnosis and disease prevention.
The team for this project has been gathering various pieces of evidence that support the existence of a pre-clinical phase of Crohn’s Disease where immunological changes are present up to 10 years before clinical diagnosis. Intercepting these changes will be transformative for patients and their families.
