MONDAY, Jan. 13, 2025 (HealthDay News) — For patients with type 1 diabetes with moderate-to-severe gastrointestinal symptoms, fecal microbiota transplantation (FMT) is safe and improves clinical outcomes, according to a study published in the January issue of eClinicalMedicine.
Katrine Lundby Høyer, from Aarhus University in Denmark, and colleagues conducted a randomized, double-blind, placebo-controlled pilot trial involving adults with type 1 diabetes and moderate-to-severe gastrointestinal symptoms. Twenty patients were randomly assigned to receive 25 capsules of encapsulated FMT, containing 50 mg of feces, administered in a single dose, or placebo capsules containing glycerol, saline, and food coloring. All patients received a second intervention of FMT.
The researchers observed no difference between the groups in adverse events, with four patients in the FMT group reporting seven adverse events and five patients in the placebo group reporting 19. Diarrhea, bloating, and abdominal pain were the most frequent adverse events. The median Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome score was reduced from 58 to 35 among patients who received FMT and from 64 to 56 among patients receiving placebo. There was improvement in the Irritable Bowel Syndrome Impact Scale score, from 108 to 140 with FMT and from 77 to 92 with placebo. There was a decline in the Patient Assessment of Gastrointestinal Symptom Severity Index from a median of 42 to 25 and from 47 to 41 after FMT and placebo, respectively.
“To our knowledge, this study represents the most promising clinical effect of FMT beyond its established efficacy in treating Clostridium difficile infection,” the authors write.
Several authors disclosed ties to the pharmaceutical and medical device industries.
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