SINT1A STUDY: PREVENTION OF TYPE 1 DIABETES
What is the SINT1A study?
The SINT1A study (Supplementation with B. INfantis for Mitigation of Type 1 Diabetes Autoimmunity) is a research study for infants with an increased risk of type 1 diabetes. The aim of the study is to prevent the development of type 1 diabetes. Infants up to the age of six weeks can participate.
Type 1 diabetes is caused by the immune system mistakenly reacting to the insulin-producing cells (beta cells) in the pancreas. The beta cells are destroyed by this mistaken reaction of the immune system. The body’s own insulin is often the first target of this immune reaction, which leads to type 1 diabetes.
The SINT1A study investigates whether giving the probiotic B. infantis can prevent the development of type 1 diabetes in children with an increased risk of type 1 diabetes. In the study, the probiotic is given orally (by mouth). The aim is for this to positively influence the intestinal flora and thus have a regulating effect on the immune system. In the study, our aim is to investigate whether this can reduce mistaken and pathogenic immune responses, such as those in type 1 diabetes, as well as other diseases, such as celiac disease, and thus prevent the disease.
Why should my child participate in the SINT1A study?
Between six months and three years old, children with an increased risk of type 1 diabetes are particularly susceptible to a mistaken reaction by the immune system against beta cells. The development of the immune system, especially during the first few months of life, is significantly influenced by bacteria and other microbes in the intestine (intestinal or gut flora), among other things. This is why it is particularly useful to take early preventive action regarding the development of the immune system in the first year of life, before any signs of destruction of the beta cells.
The SINT1A study aims to ensure healthy development of the baby’s intestinal flora by administering the probiotic B. infantis as a supplement to the daily diet. This is because previous studies such as the German BABYDIET study and the international TEDDY study showed that children with type 1 diabetes can suffer from problems with the early maturation of their intestinal flora as infants. These problems with maturation can have various causes and are also observed in connection with the occurrence of allergies and other diseases of the immune system.
If your child participates in the SINT1A study, they will be examined regularly. If your child does develop symptoms of type 1 diabetes, this can be identified at an early stage. There is no charge for the treatment and investigations carried out as part of the study.
How can my child participate?
To participate in the SINT1A study, your child must have a 10% risk of developing type 1 diabetes. The Freder1k study will identify whether your child is in this group.. Newborns up to seven days old can participate in the Freder1k study.
What happens in the SINT1A study?
Infants up to six weeks old can participate in the SINT1A study that aims to prevent type 1 diabetes. The first study visit will take place before your child is six weeks old. You will be given a powder for your child which contains either the probiotic or a placebo (inactive substance). Half of the participating children receive the probiotic, the other half receive a placebo. It is a double-blind study, which means that neither the study participants nor the study staff know who receives the probiotic or the placebo. Participants are randomly allocated to one of the two groups. Comparison with a placebo is necessary in order to evaluate the effect of the probiotic. The correct amount of the powder for one day is suppliedin a sachet. This is dissolved in liquid (preferably breast milk) and administered by mouth using a feeding syringe.
There are additional visits when the baby is six and twelve months old. Babies stop taking the powder at the age of twelve months. Afterwards, further physical examinations and blood tests are carried out by our doctors at the study centre once per year. These follow-up examinations will take place until the child is a maximum of six and a half years old (depending on when the child was enrolled in the study). Tests are run on blood samples including for islet autoantibodies, which can indicate an early stage of type 1 diabetes, and to check blood glucose levels. This can help us detect an early stage of type 1 diabetes, monitor it closely and control blood glucose. If your child does develop type 1 diabetes, we can detect the onset of the disease before symptoms appear.
Watch this video to learn more about the SINT1A study:
Who can participate in the SINT1A study?
Your child can be included in the SINT1A study if:
- They are up to six weeks old
- Testing has shown that they have an increased risk of type 1 diabetes
>> Take advantage of this opportunity: have your child tested for the risk of developing type 1 diabetes so that they can receive preventive treatment if needed.