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Comment by Aurornis | Hacker News Reader

I think this is the clinical trial registration: https://clinicaltrials.gov/study/NCT03408886?tab=results

It is marked as having results submitted but quality review has not been completed.

N=60 and a placebo group, which is better than the N=18 and no placebo group of the first study.

There have been so many small scale trials showing amazing autism improvements that failed to replicate in larger, better controlled trials. I wouldn’t get excited yet.

The typical pattern is to show unbelievably good results in the first open-label trial with a small number of patients (their n=18 trial that claims to have cured severe autism in many children), squeak by with some marginal improvement in the next trial over placebo, then the third trial becomes a game of trying to keep the study small enough that they can hope to p-hack a result that the FDA might accept.

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Study completed in 2022, but still no results posted or study published.

I've never really thought about this but, could it be because they don't want people to "try this at home"? Either because of safety issues, or my actual hypothesis, because they want to keep their possible pool of candidates as big as possible?

No, they have a patent so they would be in a hurry to publish if the results were good.

From the comments in the article above, it sounds like it may have failed it's primary outcome (autism symptoms). They only say there was significant benefit for "average of all symptoms", but it isn't clear if that is the same thing.

A lot of studies take time to release results.

Not 4 years though.

> I think this is the clinical trial registration: https://clinicaltrials.gov/study/NCT03408886?tab=results

That's a slightly different clinical trial on adults, not children like the posted article. I think this is the clinical trial registration: https://clinicaltrials.gov/study/NCT02504554. Here's the followup report in 2019: https://www.nature.com/articles/s41598-019-42183-0

That said, your reasoning is probably still correct. There's no placebo group, and a lot can change over a 2-year follow-up, with participants aged 7-17. Maybe they went to speech therapy or just matured and learned more coping behaviors. The 2019 followup also notes that 12 of the 18 participants made other diet and medication adjustments. They claim the adjustments were minor but that's still more noise, and it doesn't account for unreported social/environmental changes.

> There have been so many small scale trials showing amazing autism improvements that failed to replicate in larger, better controlled trials. I wouldn’t get excited yet.

Unfortunately yeah, it's unlikely anything exciting will replicate in a larger RCT other than maybe the gut biome improvement since that seems directly mechanistic, but that's just a gut feeling.

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