Active not recruitingNAINTERVENTIONAL

Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity

This research is trying to find out if giving a specific good bacteria, called B. infantis, to babies at high genetic risk of developing type 1 diabetes can protect them. Babies would receive this once a day from around one week old until their first birthday. The aim is to see if this helps reduce the chance of their immune system mistakenly attacking the insulin-producing cells in the pancreas. This could potentially prevent type 1 diabetes from developing later in childhood. Researchers will follow the children for several years to understand the long-term effects. The study also hopes to learn more about how this good bacteria might help the immune system in general.

At a glance

Status

Active not recruiting

Phase

Sponsor

Helmholtz Zentrum München

Enrolment target

1,149

Start

22 Apr 2021

Estimated completion

01 Oct 2027

Diabetes Mellitus, Type 1

What is this study about?

Type 1 diabetes is a condition where the body's immune system mistakenly attacks and destroys the cells in the pancreas that make insulin, a hormone essential for controlling blood sugar. This study aims to see if we can stop this process from happening in very young children who are known to be at a higher risk of developing type 1 diabetes.

Researchers are investigating whether giving these babies a special type of 'good' bacteria, called B. infantis, can help. The idea is that this bacteria might improve the balance of germs in the baby's gut, which in turn could help train their immune system not to attack their own body. If successful, this could reduce the chances of these children developing type 1 diabetes as they grow up.

This research is important because there's currently no way to prevent type 1 diabetes. By understanding if early treatment with B. infantis can make a difference, we could potentially find a way to protect children who are most vulnerable to this condition.

Key takeaways

This study investigates if a 'good' bacteria can prevent type 1 diabetes in high-risk babies.
Babies take a daily supplement (or placebo) from about one week old to one year old.
The study includes regular check-ups, phone calls, and collection of samples.
It's a 'blinded' study, meaning no one knows who gets the active supplement until the end.
Participation is voluntary, and you can withdraw your baby at any time.
The research aims to find new ways to protect children from developing type 1 diabetes.

Who may be eligible?

This study is looking for very young babies, generally between 7 days and 6 weeks old. They must have a higher genetic risk of developing type 1 diabetes. This risk is usually identified through specific genetic tests.

Babies might not be able to join if they were born very early (before 36 weeks), have certain medical conditions, or a weak immune system. They also can't take part if they have already been diagnosed with diabetes.

Importantly, a parent or guardian must be able to give their written permission for their baby to take part in the study.

Quick self-check

Is my baby between 7 days and 6 weeks old?
Does my baby have a specific genetic risk for type 1 diabetes (this would usually be identified by a doctor)?
Was my baby born at 36 weeks or later (not prematurely)?
Does my baby have any other significant health conditions or a weak immune system?
Has my baby already been diagnosed with diabetes?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your baby takes part, they will receive either the B. infantis supplement or a placebo (a dummy treatment) once a day, given by mouth, from when they join until they are about 12 months old. Neither you nor the study team will know whether your baby is receiving the supplement or the placebo until the study ends.

Your baby will have regular check-ups at the study clinic, and the team will also check in with you through phone calls and online questionnaires. These appointments may involve taking blood and stool samples from your baby to understand more about their health, gut bacteria, and immune system. Follow-up will continue until your child is between 3.5 and 6.5 years old, even after they stop taking the daily supplement.

Potential risks and benefits

There's a chance the B. infantis supplement could have a positive effect on your baby's immune system and gut health, potentially reducing their risk of type 1 diabetes. However, we don't know for sure if it will work. As with any study involving babies, there's a small risk of discomfort from things like blood tests. The study team will monitor your baby very carefully. You are completely free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (8)

University Hospitals Leuven Faculty of Medicine, Catholic University of Leuven
Leuven, Belgium
Universitätsklinikum Carl Gustav Carus Technische Universität Dresden
Dresden, Germany
AUF DER BULT, Kinder- und Jugendkrankenhaus
Hanover, Germany
Institute of Diabetes Research, Helmholtz Zentrum Munich, Germany, and Forschergruppe Diabetes, Technical University Munich (TUM), School of Medicine, Klinikum rechts der Isar
Munich, Germany
Department of Paediatrics Medical University of Warsaw
Warsaw, Poland
Lund University, Skane University Hospital SUS
Malmö, Sweden
University Department of Paediatrics, Cambridge Biomedical Campus
Cambridge, United Kingdom
Royal Victoria Infirmary, Newcastle upon Tyne
Newcastle, United Kingdom

Common questions

What is B. infantis?

B. infantis is a type of 'good' bacteria normally found in a healthy gut, especially in babies. Researchers are studying if giving more of it can help prevent certain diseases.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real supplement but doesn't contain any active ingredients. It's used to fairly compare the effects of the real supplement.

How long will my child be in the study?

Your child will receive the study product until they are about 12 months old, and then will be followed up with check-ups until they are between 3.5 and 6.5 years old.

Why are blood and stool samples needed?

These samples help researchers understand how the supplement might be affecting your baby's health, immune system, and the overall balance of bacteria in their gut.

Will I know if my baby received the real supplement?

No, during the study, neither you nor the doctors will know. This is called 'double-blind' and helps ensure the study results are as accurate as possible. You'll find out after the study finishes.