FMT Shows Early Success in Type 1 Diabetes With Bowel Issues

TOPLINE:

In patients with type 1 diabetes and severe gastroenteropathy, fecal microbiota transplantation (FMT) demonstrates a favorable safety profile and is more effective than placebo in alleviating gastrointestinal symptoms and improving quality-of-life outcomes.

METHODOLOGY: 

• Diabetic gastroenteropathy commonly affects individuals with type 1 diabetes, causing debilitating symptoms like nausea, vomiting, bloating, and diarrhea; however, treatment options remain limited.
• Researchers conducted a novel clinical trial to test the benefits of FMT in adult patients with type 1 diabetes and severe symptoms of gastroenteropathy, who were randomly assigned to receive either FMT or placebo capsules as the first intervention.
• After 4 weeks, all patients received FMT capsules as the second intervention.
• Stool samples were collected at baseline and 4 weeks after each intervention to evaluate changes in gut microbiota.
• The primary endpoint was the number of adverse events of severity grade ≥ 2 during the week following the first intervention. The secondary endpoints included change in gastrointestinal symptoms and quality of life from baseline to 4 weeks after the first intervention.

TAKEAWAY:

• Researchers included 20 patients (median age, 46 years; 30% men), with a median type 1 diabetes duration of 31 years.
• There were seven adverse events in four FMT recipients vs 19 adverse events in five placebo recipients, with no difference between the groups (relative risk, 0.80).
• The most frequent adverse events were diarrhea, bloating, and abdominal pain, with no serious adverse events deemed related to treatment.
• Patients receiving FMT showed a significantly greater reduction in Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome scores (P = .01) and Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (P = .03) and a significantly greater improvement in quality-of-life outcomes (P = .02) than those receiving placebo.
• Significant reductions in subscores for bloating and upper abdominal pain were also observed in the FMT group compared with the placebo group.
• Compared with placebo, FMT led to significant changes in the diversity of the gut microbiome.

IN PRACTICE:

“This is the first time FMT has been tested specifically in this patient group with placebo as a control,” Katrine Lundby Høyer, MD, the lead author, said in a press release. “The method has great potential, and we hope to replicate the study on a larger scale to ensure more patients can benefit.”

SOURCE:

This study, led by Katrine Lundby Høyer, MD, Department of Hepatology and Gastroenterology, Aarhus University Hospital in Aarhus, Denmark, was published online in eClinicalMedicine.

LIMITATIONS:

This was a pilot study with a small sample size, and adverse events and clinical recurrences in gastrointestinal symptoms may still occur with longer follow-up. Most participants had severe gastrointestinal symptoms and significantly prolonged gastric emptying time, and it remains unclear whether patients with less severe symptoms would benefit from FMT. No validated questionnaires existed specifically for assessing the symptoms of gastroenteropathy among patients with type 1 diabetes.

DISCLOSURES:

This study was funded by an independent Steno Collaborative Grant. Some authors reported receiving grants, consulting fees, and lecture honoraria from, as well as serving on the advisory boards of, several pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.