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New clinical study aims to prevent type 1 diabetes in children

Type 1 diabetes is the most common metabolic disease in children and adolescents worldwide. It can be particularly dangerous as often there is no diagnosis until severe and sometimes life-threatening symptoms have already developed. The new ‘SINT1A‘ study explores the potential of a specific probiotic to strengthen the immune system early-on in children with increased genetic risk of type 1 diabetes, and thus prevent its development. Middle East Health reports.

Around one in 300 children and adolescents are diagnosed with the autoimmune disease type 1 diabetes by 18 years of age. Around 90 percent of patients do not have a close relative with type 1 diabetes, meaning the disease can affect any child without a disease history in their family. People with type 1 diabetes must inject the hormone insulin for the rest of their lives because their immune system attacks the insulin-producing cells in the “islets” of their pancreas. Insulin has a vital function, transporting sugar from the blood into the body’s cells. The body’s own insulin is often the first target of the immune reaction which leads to type 1 diabetes.

Improving the immune system with probiotics
In early stages of type 1 diabetes, so-called islet auto-antibodies appear in the blood as a result of the immune system attacking the insulin-producing cells. Researchers know from earlier studies that children who develop these antibodies can suffer from imbalances in their intestinal flora in early childhood. The new SINT1A Supplementation with B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity) study aims to prevent the occurrence of islet autoantibodies in children with an increased genetic risk of type 1 diabetes by administering a probiotic containing a strain of Bifidobacterium Infantis (activated B. infantis EVC001) together with their daily nutrition. This is hypothesized to promote a healthy and balanced development of the intestinal flora, which is thought to have beneficial effects on the immune system before the first signs of autoimmunity appear.

SINT1A follows the ongoing Primary Oral Insulin Trial (POInT), which administers insulin orally to train and sensitize the immune system at an early stage so that autoimmunity against insulin does not occur.

“We believe that the immune system of the oral and gut mucosa is very important for preventing immune-mediated diseases like type 1 diabetes. The POInT study uses the gut to familiarize the immune system with insulin and prevent an autoimmune response against it. SINT1A was designed based on the knowledge that a healthy gut microflora reduces inflammation and this helps the immune system better distinguish antigens that are safe from those that are dangerous,” explained Dresden study leader Ezio Bonifacio, Professor at the Medical Faculty and Center for Regenerative Therapies Dresden (CRTD) at the TU Dresden, Germany.

In this way, the SINT1A investigators want to reduce the chances that children with a high genetic risk of developing type 1 diabetes start immune responses that lead to autoimmunity.

“If the results for both studies show what we are hoping for,” explained Prof. Bonifacio, “we will aim to combine both studies for an optimized synergistic type 1 diabetes prevention strategy. Type 1 diabetes could be transformed from a previously unavoidable fate into a disease that can be prevented.”

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

SINT1A, POInT and the newborn screening study are part of GPPAD. The GPPAD studies are led by Helmholtz Zentrum München. All data generated in the GPPAD studies aim to serve scientific progress that might eventually benefit patients. Therefore, GPPAD makes pseudonymized data and samples from the biobank available to the scientific community upon request.


• Learn more about GPPAD data sharing:https://www.gppad.org/en/data-sharing/

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