Aarhus University Hospital researchers have found that fecal microbiota transplantation (FMT) may offer relief for type 1 diabetes patients suffering from gastrointestinal issues. The randomized, double-blind, placebo-controlled trial provides early evidence that FMT can be an effective add-on to diabetes care by improving gut health.
The study, published in eClinicalMedicine, involved 20 type 1 diabetes patients with moderate to severe gastrointestinal problems. Participants were randomized to receive either 25 capsules containing donor feces or a placebo, followed by a crossover after four weeks where all participants received FMT.
The results indicated that patients who initially received FMT experienced a greater reduction in gastrointestinal symptoms. Using the Patient Assessment of Gastrointestinal Symptom Severity Index (scored from 0 to 100), the FMT group's median score dropped from 42 to 25, while the placebo group saw a decrease from 47 to 41. Researchers also observed changes in the patients' gut microbiomes following FMT. Importantly, the reported adverse events were similar between both groups, suggesting FMT's safety.
Impact on Quality of Life
Beyond symptom reduction, the study also assessed the impact on quality of life. Patients receiving FMT experienced an increase in quality of life scores from 108 to 140 (scale assessing the impact of irritable bowel syndrome), while placebo patients improved from 77 to 92.
The Potential of FMT
"Our findings suggest that FMT may represent a potential new therapeutic option that could fundamentally transform the current approach to treating bowel symptoms in patients with type 1 diabetes," the researchers wrote. They also noted, "To our knowledge, this study represents the most promising clinical effect of FMT beyond its established efficacy in treating Clostridioides difficile infection."
Current Treatment Landscape and Unmet Needs
Type 1 diabetes, an autoimmune condition affecting insulin production, often leads to other health problems, including gastrointestinal issues. Existing treatments primarily focus on managing blood sugar levels, leaving a gap in addressing the gut-related complications experienced by many patients. As many as a quarter of type 1 diabetics suffer from diabetic gastroenteropathy, a condition in which the nerves that regulate the GI tract become damaged.
Limitations and Future Directions
The researchers acknowledge the small sample size as a limitation and emphasize the need for larger studies to validate these findings. More research is needed to study the long-term effects of fecal transplant on these patients, and figure out if some patients would benefit more than others.
"We now need to investigate how the treatment can be implemented more broadly and ensure it becomes accessible to patients with the greatest need," said senior researcher Dr. Klaus Krogh.
