Can insulin taken as an infant in small doses together with food render the immune system used to insulin and thus prevent type 1 diabetes? Can a gluten-free diet and probiotics prevent celiac disease (so called gluten intolerance)? These questions will be asked by two separate studies that are being planned at Lund University in Sweden. A new comprehensive screening of newborn babies in southern Sweden is projected to commence this spring, in order to identify children with an elevated risk of type 1 diabetes or celiac disease.
Lund University has received a grant of more than SEK 3 million over one year from The Leona M. And Harry B. Helmsley Charitable Trust to get ready for screening of newborn children.
“We will be looking for children with increased hereditary risk for type 1 diabetes or celiac disease with the hope of preventing the onset of these diseases”, says Jeanette Åkerström Kördel, who is the study coordinator.
The screening is intended to identify children with increased hereditary risk of autoimmune type 1 diabetes or celiac disease and ask the parents to participate with their baby in two new studies. A blood sample will be taken from the child’s umbilical cord, which is both risk-free and painless.
Half of the children in the autoimmune type 1 diabetes study are planned to be given oral insulin; the other half a placebo. They will receive one dose per day from the ages of 4–7 months until they turn three years of age. The insulin (or placebo) is an odourless, taste-free powder made up of tiny crystals to be consumed in small portions. It comes in small capsules which are opened and the content is mixed with food. The dosage has been tested in previous studies, and has not shown to affect blood glucose levels. In addition to the daily insulin dose, the participants will be carefully monitored at the study clinic on a regular basis. Monitoring visits includes leaving blood samples.
“Preliminary studies in newborns who have received oral insulin show no side effects. The insulin is to affect the immune system’s cells in the oral cavity, such as the tonsils. We hope to prevent children from having an autoimmune reaction to their own insulin”, says paediatrician and associate professor Helena Elding Larsson, who will be responsible for the type 1 diabetes study.
The celiac disease study also includes regular visits to the study clinic.
“In our study, there will be three groups of children. One group will be given a gluten-free diet, a second group will receive a non-gluten-free diet and probiotics, and the third group will receive a non-gluten-free diet and placebo ”, says paediatrician and associate professor Daniel Agardh, who will be responsible for the celiac disease study.
The screening is expected to result in at least 300 children for each study. The studies are planned to commence later in 2018.
Facts/autoimmune diabetes and celiac disease:
Autoimmune type 1 diabetes develops when the body’s own immune system completely or partially destroys the body’s beta cells that produce insulin. The presence of one or more (multiple) autoantibodies against protein located in the beta cells is an indication that this development has begun, in which case the child may have developed diabetes within 1–2 years. The screening hopes to identify children with a genetic make-up specific to diabetes, entailing a 10 per cent risk of developing multiple autoantibodies before the age of six, compared to just over half a per cent of the rest of the population.
Celiac disease (so called gluten intolerance), occurs when the intestinal mucosa is attacked. The screening hopes to identify girls with a genetic make-up specific to celiac disease, who have as much as a 30 per cent risk of developing celiac disease before the age of six.