Probiotics for Type 1 Diabetes

This trial explores how probiotics might help manage Type 1 diabetes (T1D) by balancing gut bacteria. Researchers believe gut imbalances could worsen T1D and aim to determine if probiotics can improve this condition. Participants will receive either Visbiome, a probiotic treatment, or a placebo (a harmless pill with no active ingredients) to compare effects. The trial seeks young people, ages 5-17, diagnosed with T1D in the last 90 days and possessing certain diabetes-related antibodies. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in T1D management.

The trial does not specify if you need to stop taking your current medications, but you cannot have used probiotics within 1 month before the screening. If you have a severe, active disease that requires chronic medication, you may not be eligible, except for well-controlled autoimmune thyroiditis/hypothyroidism.

Research shows that Visbiome, the probiotic used in the study, is generally well-tolerated. Studies have found that participants usually take it without problems, and no negative side effects have been reported. With over 70 published, peer-reviewed, controlled trials, Visbiome ranks among the most researched probiotics available. This extensive research suggests that Visbiome is safe for use.¹²³⁴⁵

Unlike the standard treatments for Type 1 Diabetes, which typically involve insulin therapy, Visbiome is a probiotic formulation that introduces beneficial bacteria to the gut. This new approach is exciting because it may help modulate the immune system, potentially reducing the autoimmune attack on insulin-producing cells. Researchers are particularly interested in Visbiome's ability to provide a natural, gut-focused strategy that could complement or even enhance traditional diabetes management.

Studies have shown that Visbiome, a potent probiotic with multiple strains, can help individuals with Type 1 Diabetes manage blood sugar levels more effectively. In children recently diagnosed with Type 1 Diabetes, those who took probiotics alongside their usual treatments achieved better blood sugar control and required less insulin. Another study found that probiotics significantly lowered fasting blood sugar levels by about 31.24 mg/dL. This trial will evaluate Visbiome as an experimental treatment, while another group will receive a placebo. These findings suggest that altering gut bacteria with probiotics like Visbiome might enhance the overall health of people with Type 1 Diabetes.²³⁴⁶⁷