New ‘SINT1A‘ research explores potential of a probiotic to stop kind 1 diabetes in kids

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Type 1 diabetes is the most common metabolic disease in children and adolescents worldwide. It can be particularly dangerous as it is often the case that a diagnosis is not made until severe and sometimes life-threatening symptoms have developed. The new ‘SINT1A’ study examines the potential of a certain probiotic to strengthen the immune system at an early stage in children with an increased genetic risk for type 1 diabetes and thus prevent its development.

SINT1A is managed by the Helmholtz Zentrum München and is part of the international GPPAD initiative, which also includes Prof. Ezio Bonifacio and his team at the Center for Regenerative Therapies Dresden at the TU Dresden.

About one in 300 children and adolescents is diagnosed with the autoimmune disease type 1 diabetes by the age of 18. Around 90 percent of patients do not have a close relative with type 1 diabetes, which means the disease can affect any child in their family with no history of illness.

People with type 1 diabetes must inject the hormone insulin for the rest of their lives because their own immune system attacks the insulin-producing cells in the “islands” of their pancreas. Insulin has an important function and transports sugar from the blood to the body’s cells. The body’s own insulin is often the first target of the immune response that leads to type 1 diabetes.

Improving the immune system with probiotics In the early stages of type 1 diabetes, so-called islet autoantibodies appear in the blood when the immune system attacks the insulin-producing cells. Researchers know from previous studies that children who develop these antibodies can experience imbalances in their gut flora in early childhood.

The new SINT1A study (Supplementation with B. Infantis to Reduce Type 1 Diabetes Autoimmunity) aims to prevent the occurrence of islet autoantibodies in children with an increased genetic risk for type 1 diabetes by using a Probiotic that contains a strain of Bifidobacterium Infantis (activated B infantis EVC001) is administered along with their daily diet. It is believed that this promotes healthy and balanced development of the intestinal flora, which is believed to have beneficial effects on the immune system before the first signs of autoimmunity appear.

SINT1A follows the ongoing primary oral insulin study (POInT), in which insulin is administered orally to train and sensitize the immune system early on so that there is no autoimmunity to insulin.

We believe that the immune system of the lining of the mouth and intestines is very important in preventing immune-mediated diseases such as type 1 diabetes. The POInT study uses the gut (where oral insulin arrives) to familiarize the immune system with insulin and prevent an autoimmune reaction against it. SINT1A was developed based on the knowledge that healthy gut flora reduces inflammation and this helps the immune system better differentiate antigens that are safe from those that are dangerous. “

Prof. Ezio Bonifacio, Head of Studies, TU Dresden

In doing so, the SINT1A researchers want to reduce the likelihood that children with a high genetic risk of developing type 1 diabetes will trigger immune responses that lead to autoimmunity. “If the results of both studies show what we hope for,” explains Prof. Bonifacio, “we want to combine both studies for an optimized synergistic strategy for the prevention of type 1 diabetes. Type 1 diabetes could be of a previously unavoidable fate to be transformed into a disease. ” that can be prevented. “

The SINT1A study will begin in April 2021 in several European countries as part of GPPAD (Global Platform for the Prevention of Autoimmune Diabetes) – an international initiative for the prevention of type 1 diabetes. The GPPAD research sites are located in Belgium (Leuven), Germany (Dresden, Hanover, Munich), Poland (Warsaw), Sweden (Malmö) and Great Britain (Cambridge, Newcastle).

Newborn screening for type 1 diabetes risk Participation in the SINT1A and POInT studies requires evidence of an increased genetic type 1 diabetes risk. Newborn screenings make it possible to identify this risk well before the disease manifests. The test can be performed with a few drops of blood within the first 7 days of life. For this purpose, Prof. Bonifacio and his team started a newborn screening program in 2016 (known in Germany as “Freder1k”). “Together with the strong scientific network of GPPAD, we were able to examine 245,000 babies in international newborn screenings. We found an increased genetic risk in 1.15 percent. Early detection is essential for meaningful preventive measures,” says Prof. Reinhard Berner, director of the children’s hospital.

Research on the prevention of type 1 diabetes

The Leona M. and Harry B. Helmsley Charitable Trust is funding the new SINT1A study and the continuation of the established newborn screening with more than 30 million US dollars. “At Helmsley, we are committed to investing in bold ideas,” said Dr. Anne Koralova, Helmsley Program Director. “GPPAD is one of our biggest investments because it shows promise and is the kind of international collaboration that is required for scientific breakthroughs.”