Faecal microbiota transplantation flops for Parkinson’s disease

In the treatment of Parkinson’s disease (PD), faecal microbiota transplantation (FMT) is safe but does not appear to deliver clinically meaningful improvements, according to a study.

For the study, 229 PD patients who were between 35 and 75 years of age, were in Hoehn & Yahr stage 1–3, had a mild to moderate symptom burden, and presented with dysbiosis of faecal microbiota were screened. Of these, 48 were randomly assigned to receive FMT or placebo via colonoscopy within 60 days.

FMT involved a freeze-stored preparation of 30 g of faeces from one of two healthy donors, mixed with 150 mL of sterile physiological saline and 20 mL of 85% glycerol for cryoprotection to improve viability of microbes. Placebo, on the other hand, was a solution of 180 mL of sterile physiological saline and 20 mL of 85% glycerol.

A total of 45 patients were included in the intention-to-treat analysis, including 30 in the FMT group (median age 66 years, 53.3 percent male) and 15 in the placebo group (median age 65 years, 60.0 percent male).

The primary endpoint of change in Movement Disorder Society Unified Parkinson’s Disease Rating Scale parts I-III (part III off medication) at 6 months did not significantly differ between the FMT and placebo groups (0.97 points, 95 percent confidence interval [CI], −5.10 to 7.03; p=0.75).

In terms of safety, gastrointestinal adverse events occurred with greater frequency in the FMT group than in the placebo group (53 percent vs 7 percent; p=0.003).

In secondary outcomes and post hoc analyses, placebo recipients demonstrated improvements in certain motor and nonmotor outcomes, which were accompanied by greater dopaminergic medication use. Meanwhile, FMT recipients showed more pronounced microbiota changes, which differed by donor. However, the rate of dysbiosis reversal was higher in the placebo group.