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Fecal transplants for autism deliver success in clinical trials (2019)

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Re: Fecal transplants for autism deliver success in clinical trials (2019)

#71

Post by tt_dev »

senfiaj wrote: post #65

I would still be cautious with such findings. Many autistic people are picky eaters, also some of them have issues with peristalsis. This might affect the microbiome as well. While it's plausible that it might help a subset of people, we should not overgeneralize since autism is a very heterogeneous condition, usually with pronounced genetic predisposition. Overall, it doesn't seem to be a cure.

I had a similar question to. From my understanding of the study, which was double blind placebo study, it does not treat autism but its shown to greatly improve symptoms of autism.

They basically wiped the gut clean with antibiotics then started treating and saw improvements.

Could be that GI issues increase irritability which makes the measured autism symptoms more aggressive but it looks very promising for families.

Not affiliated just read the study.

Re: Fecal transplants for autism deliver success in clinical trials (2019)

#72

Post by rossdavidh »

senfiaj wrote: post #65

I would still be cautious with such findings. Many autistic people are picky eaters, also some of them have issues with peristalsis. This might affect the microbiome as well. While it's plausible that it might help a subset of people, we should not overgeneralize since autism is a very heterogeneous condition, usually with pronounced genetic predisposition. Overall, it doesn't seem to be a cure.

True that, but it could be both cause and effect. There are reports that gut bacteria can induce depression, which benefits the bacteria because it sends more calorie-rich, highly processed food down the gullet (think ice cream binges when depressed). Not hard to believe that gut bacteria optimized for a particular kind of food could evolve the ability to induce their host to eat that food exclusively. It would have the side-benefit (for the bacteria) of reducing competition from other microbes that aren't optimized for that, by starving them out. Things aren't always just cause or effect, especially in biology.

Re: Fecal transplants for autism deliver success in clinical trials (2019)

#73

Post by rzmmm »

freehorse wrote: post #28
geremiiah wrote: post #14

What's more plausible? Did they cure low functioning autism in two years? Or did they simpily miscategorize the kids and the kids grew out of their diagnosis as they matured?

They say that they started a phase 2 trial with placebo control in 2022 and they see better outcome than placebo > Our phase 2 study for adults with autism found that the treatment group improved more than placebo on the primary outcome (autism symptoms) and on a secondary outcome (daily stool record),

Looks like this is the placebo-controlled trial https://clinicaltrials.gov/study/NCT03408886

I can't find full analysis but the primary autism-symptom outcome improved by 9% in treatment group and 4% in controls. I guess there is no statistical significance because that metric likely has high variance.

In abnormal stools there was 42% improvement in treatment vs 23% in control.

The combination of GI disorder and autism in these trials make blinding almost impossible. The patients will notice if the GI symptoms change. And the results seem to be that this fecal transplant has larger effect for the GI part anyway.

Re: Fecal transplants for autism deliver success in clinical trials (2019)

#75

Post by jcattle »

_puk wrote: post #42

>> In early 2022 Krajmalnik-Brown and colleagues patented a specific bacterial formulation and spun-off a commercial company called Gut-Brain Axis Therapeutics. I was a little surprised to see this. So the university researchers use time and money from the university to make a discovery, extending on previous published research, and then patent it and start their own for-profit? Excuse my ignorance, but is that how i…

This is how it works. Universities are doing research, they aren't doing products. If a commercially viable product comes out of their research it is far outside the scope of universities.

Also keep in mind that most sciences usually don't produce commercially viable research (think social sciences, archeology, geography etc.)

And as others said: how the universities gets a cut from the spin offs differs from university to university.

Re: Fecal transplants for autism deliver success in clinical trials (2019)

#77

Post by 47282847 »

jwrallie wrote: post #39
motoboi wrote: post #34

Earlier quoted context omitted.

The microbiota is passed from mother to son on birth, not totally from the environment. What we currently don’t understand is why for some people they never got them (we have techniques to transport the biota from the mother during birth for non-natural procedures) or they loose them. Even with the transplant, the microbes won’t stick around on those people (not taking about autistic people here, but people in genera…

In some countries the number of kids born through c-section are very high, more than half the kids in Brazil are born that way for example, so definitely people can be healthy without getting it from their mothers.

> can be healthy

Or can they.

It’s (meant to be) an emergency procedure. Benefits: life. Downsides: plenty.

Maybe most relevant in the context of this thread:

“In this systematic review and meta-analysis of 61 studies comprising more than 20 million deliveries, birth by cesarean delivery was significantly associated with autism spectrum disorder and attention-deficit/hyperactivity disorder.“

Zhang, T., Sidorchuk, A., Sevilla-Cermeño, L., Vilaplana-Pérez, A., Chang, Z., Larsson, H., Mataix-Cols, D., Fernández de la Cruz, L., & D’Onofrio, B. M. (2019). Association of cesarean delivery with risk of neurodevelopmental and psychiatric disorders in the offspring: A systematic review and meta-analysis. JAMA Network Open, 2(8), e1910236. https://doi.org/10.1001/jamanetworkopen.2019.10236

A selection of some more:

Keag, O. E., Norman, J. E., & Stock, S. J. (2018). Long-term risks and benefits associated with cesarean delivery for mother, baby, and subsequent pregnancies: Systematic review and meta-analysis. PLOS Medicine, 15(1), e1002494. https://doi.org/10.1371/journal.pmed.1002494

De Mucio, B., Serruya, S., Alemán, A., Castellano, G., & Sosa, C. G. (2019). A systematic review and meta-analysis of cesarean delivery and other uterine surgery as risk factors for placenta accreta. International Journal of Gynecology & Obstetrics, 147(3), 281–291. https://doi.org/10.1002/ijgo.12948

Sandall, J., Tribe, R. M., Avery, L., Mola, G., Visser, G. H. A., Homer, C. S. E., Gibbons, D., Kelly, N. M., Kennedy, H. P., Kidanto, H., Taylor, P., & Temmerman, M. (2018). Short-term and long-term effects of caesarean section on the health of women and children. The Lancet, 392(10155), 1349–1357. https://doi.org/10.1016/S0140-6736(18)31930-5

Li, H.-T., Zhou, Y.-B., & Liu, J.-M. (2013). The impact of cesarean section on offspring overweight and obesity: A systematic review and meta-analysis. International Journal of Obesity, 37(7), 893–899. https://doi.org/10.1038/ijo.2012.195

S., Fleming, J., Bromley, A., Shields, M. D., & Cardwell, C. R. (2008). A meta-analysis of the association between Caesarean section and childhood asthma. Clinical & Experimental Allergy, 38(4), 629–633. https://doi.org/10.1111/j.1365-2222.2007.02780.x

Mascarello, K. C., Horta, B. L., & Silveira, M. F. (2017). Maternal complications and cesarean section without indication: Systematic review and meta-analysis. Revista de Saúde Pública, 51, 105. https://doi.org/10.11606/S1518-8787.2017051000389

Re: Fecal transplants for autism deliver success in clinical trials (2019)

#78

Post by shermantanktop »

delichon wrote: post #26

I got bad chronic constipation after four years as a strict carnivore. I didn't get relief just by adding back fiber, but I did by adding fermented foods like kimchi. I wonder if ferments are a more natural way than fecal transplants to repair the gut microbiome, possibly treating autism. Studies have been non conclusive, but this story makes me think it's worth pursuing.

The lower intestinal region is guarded by a vat of acid. Not sure how much of those probiotic pills get through.

Re: Fecal transplants for autism deliver success in clinical trials (2019)

#79

Post by stephenitis »

dimes wrote: post #70
directevolve wrote: post #56

Many autistic children have extremely limited diets. For example, a geneticist friend of mine saw a case where an autistic child had been referred for genetic testing because of horrific, chronic, spontaneous wounds on gums and skin. Turned out to be scurvy, because he had exclusively eaten Wheat Thins for the last 3-4 years, which aren’t fortified with vitamin C. I would fully expect that a monotonous diet leads to…

Just to play devil’s advocate, isn’t it also possible that the preference for a monotonous diet is driven by gut makeup?

You seed the gut with nutrients. having lots of fiber and a varied diet increases the number of species that an adult has which is between a couple hundred to a thousand or so. Our guts are generally dominated by a bunch of beneficial bacteria.

which for many is not the case for a variety of social economic or behavioral reasons. Add in with explosions of bacterial populations due to alcohol or sugar and you can see how we can change our gut biome drastically from week to week.

Re: Fecal transplants for autism deliver success in clinical trials (2019)

#80

Post by Aurornis »

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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