Effect of oral faecal microbiota transplantation intervention for children with autism spectrum disorder: A randomised, double-blind, placebo-controlled trial (Aug 2024, n=103) "FMT did not significantly improve clinical symptoms" FMT

[Michael Harrop]

https://onlinelibrary.wiley.com/doi/10.1002/ctm2.70006

Their adverse event tracking is much better than the majority of other FMT studies. They list a variety of categorized adverse events in TABLE 3.

Of course, bad donors as usual. They don't even cover donor criteria.

We conducted a randomised, double-blind, placebo-controlled trial of an oral faecal microbiota transplantation (FMT) intervention in children with autism spectrum disorder (ASD), and observed that there were differences in pre- and post-FMT intervention changes in the social domain scores of the Vineland Adaptive Behaviour Scale, third version (Vineland-3), with no severe adverse events (AEs) related to FMT occurring.

A total of 103 eligible participants (Figure 1) were enrolled and randomised to receive either FMT or a placebo. These agents were administered during two 6-day periods in the hospital, the first occurring in the initial week and the second in the fifth week of the study. Patients were not hospitalised during the interval between treatments. FMT capsules from five healthy donors were randomly provided to 8, 8, 11, 7 and 18 patients, respectively, with each patient receiving capsules from the same donor throughout the treatment process.

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