I would fully expect that a monotonous diet leads to a heavy skew in the gut microbiome as specific bacterial species that thrive on that diet are selected for, others against. It makes some sense that a fecal transplant could repair the damage. If the diet has shifted or expanded, the transplant could lead to long term benefits by restoring newly-viable bacterial species, perhaps by facilitating digestion of the new types of food.
I’d be curious to see a factoring out of the diet composition, gut microbiome, genetics, and severity of autism symptoms.
The theories for how gut-brain axis modulation works include altering the balance of nutrients that get absorbed and modulating the vagus nerve, primarily. For someone with autism it might be possible that altering some of these balances could make the condition better or worse, but that’s all theory without much foundation.
What is known, however, is that diet has a massive impact on the microbiome. Even the mechanism for that is obvious: Bacteria thrive on different foods, so if you eat more of one class of nutrients and less of another then the microbiome proportions will adjust based on which ones thrive on that diet.
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.
Now that is something that should be done more often - especially in science journalism, but not only. We cruelly lack long-term vision - not only forward but backwards too.
There’s a subtext here that isn’t immediately obvious without reading more from the company trying to commercialize this formula: Their small phase 2 trial is underway but results haven’t fully been released as far as I can tell. It appears they’re trying to do a PR push based on their early claims of positive results, before publishing everything. If anyone can find more details please correct me if I’m wrong.
This can be a little suspicious when companies do this because before the full results are available because it’s usually associated with a rushed push to drive investor interest at the time they think it’s most optimal. When the optimal PR push timing is before full results are released, it’s not a good signal that the results are on track to be great.
It isn't a good one.
When I looked at preclinical for one of their competitors, that was the exact same thing, the issue was study design. Specifically, you are shoving something up an autistic kid's butt once a day or twice a day. They only did this to the placebo arm for 3 days, and only to healthy kids, whereas the treatment arm did this for 8 weeks.
If I punched you in the chest as hard as I could once or twice a day, do you think you'd have a behavioral change? That's their endpoint. If I called it a "medical" punch, does that change anything?
Can an autistic kid learn how to answer a test to get the thing to stop being shoved up their butt? I think so. By all means though, I encourage people to make this risky investment if they think this treatment pathway is real. It sort of is! If you want a behavioral change, we have a good idea of a way to get that from defenseless kids. But not for a good reason.
Maybe science journalism should just adopt a wiki-model instead, where there is one article per "subject" then any new (confirmed?) information/data goes into that, and interested people can subscribe to updates there instead.
Wikis generally have much better long-term maintenance given the right individuals running it, compared to a "publication journal" where things tend to get out of date eventually, with no way of actually seeing when old articles get updated.
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.
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 it's done generally? Where's the upside for all those who are potentially affected?
It kinda makes sense - Presumably the university is involved somewhere still, and it needs to be commercialised somehow, but..
https://skysonginnovations.com/startups/list/
It's interesting they got a lot of funding from over 100 families with autism children:
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.
Universities love this and encourage it. Any big place will have an office of "technology transfer" or similar to help researchers make this happen.
> Pregabalin was discovered largely on the basis of publicly funded research at Northwestern University
it happens all the time, and in many countries. Its quite common in the UK.
Don’t worry, the money is usually coming from taxpayers so the universities don’t have to dip into their endowments
In terms of why the public funds research, your statement might be true, but isn’t addressing the concern that many in the public have raised before: the results of the research should be public, given that the research was publicly funded. We have laws about open access to government functions, so why is research different?
The alternatives are lengthy court battles between universities and their best (e.g. most commercial) researchers. This creates bad PR for the university and uncertainty for the researcher & their startups because potential investors don't like open court cases.
So people came around to make this kind of license fee contract and researchers check it before deciding to join a certain university.
Not a fan of gene / bacteria patents though.
Pretty incredible if true!
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.
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 general).
Diverse food really helps, just as not eating ultraprocessed (they won’t reach the end of the intestines).
Fermented and other pre or probiotics will really help too.
But none of those will recover the biota in some people.
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
You feel satiated and you're reducing your caloric intake. You can only eat so much beef jerky compared to eating a whole bag of chips before getting sick. It's helpful for people who are binge eaters.
2 questions:
1) Did your constipation start right after you did strict carnivore? Or was it after 4 years?
2) List all foods that you ate on strict carnivore. (Include salt, water etc. I presume it won't be a long list)
2) beef, butter, chicken, pork, lamb, eggs, bacon, for > 95%. I do indulge in some processed meats with seasonings. Salt is the only seasoning I add, so I've become a salt snob and get the premium stuff.
After that unspicy diet, full strength kimchi is an experience.
> 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),
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.
However they say they also have an adult trial running that seems to show similar effects, so there might be something more into it.
An environment in which one person can thrive, labour, and enjoy life could be boring or incomprehensible or unduly stressful to another. I know people who would be diagnosed "low-functioning" if assessed in an everyday environment, but "high-functioning" if assessed in a clinical environment, and I know people who might not be diagnosed at all in an everyday environment but would be diagnosed with several seconds of acronyms in a clinical environment; and I know people who've been able to fight to get themselves an everyday environment that works for them, and I know people with vast potential who have conceded that fight and are rotting in the social care system.
If you eliminate what "should not be a factor" from the diagnostic process, then you eliminate the high-functioning / low-functioning distinction entirely. But all models are wrong, and some models are useful: while I find this particular model distasteful, there are contexts where it is necessary to get people in an environment where they can thrive (which, for children, usually means getting their parents the support they need, and occasionally the education).
At the same time, gut microbiota is extremely complex to study.
So, this may be a plausible result. I cannot judge the plausibilities right away in the way you suggest it.
More like fecal food?
EDIT: looks like I was right, it can be done that way: https://en.wikipedia.org/wiki/Fecal_microbiota_transplant#Me...
I understand a newborn gets its microbiota naturally by contact with the mom in the first days, maybe all the sterile environment involved in surgery changes that.
All applicants will be fed recycled byproducts for free.
An unexpected result for sure.
It's like the medical community wants all high functioning autistics to get bullied like hell in their formative years. Similar irony to "lisp" being unpronounceable by the very people who have a lisp.
https://news.asu.edu/20190409-discoveries-autism-symptoms-re...
actual paper:
> Prior to the study, 83% of participants had "severe" autism. Two years later, only 17% were rated as severe, 39% as mild or moderate, and incredibly, 44% were below the cut-off for mild ASD.
Emphasis mine. If you are below the cutoff for mild ASD you wouldn't be diagnosed at all.
Which leads me to wonder if for some of these children is the root cause just gut issues.
If all they have figured out how to so is treat significant gut issues that sounds very promising.
(Without a control group, you have questions about how people of that age generally progress, and what other treatment/therapies they receive over those 2 years. The phase 1 trial was with children whose parents presumably sought ever possible way to help them, while the placebo controlled phase 2 was adults who may have plateaued.)
That makes sense, since ASD is a disorder classification and is mainly relevant for treatment and benefits. Plenty of autistic people are not diagnosed with ASD.
The article certainly could do more to differentiate between the autistic spectrum itself and the diagnosis of ASD, but as long as you know not to conflate the two, it seems perfectly clear to me.
(They run a tube through your nose, down your throat, through the stomach to the top of the intestines, and introduce the bacterial slurry there.)
Also, "fecal transplant" is marketable only to weirdos. "Probiotic infusion" would work better.
For those who want to gain some artistic talent, there's this (but is expensive):
You want to land a substantial amount of, ahem, shit in there, since don't just want it to colonize one portion of the gut, and it's got quite a lot of competition.
So you would be talking a truly astonishing number of pills, I think, to compare to the volume you can manage with a tube.
WP suggests that it's about 100g (or 100000mg) of actual feces then mixed in a larger volume of saline or milk, and you'd probably need to have additional volume for assumed losses and whatever coating you think would work.
That is a _huge_ amount to put in pills.
The shortest safe path is via the nostril.
Is kind of impressive.