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Latest fecal transplant study: gut and autism symptoms improve after abx+fc treatement

Discussion in 'Other Health News and Research' started by natasa778, Jan 26, 2017.

  1. natasa778

    natasa778 Senior Member

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    Autism symptoms improve after fecal transplant, small study finds



    == two weeks of antibiotics, followed by two weeks of high dose fc (SHGM formula), followed by seven-eight weeks low dose fc.


    Full paper here
     
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  2. Murph

    Murph :)

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    I'd never heard of SHGM. It seems to be made from stool, but concentrated. Here's what the paper says.

    >
    Standardized human gut microbiota
    Instead of pure stool, this study involved the use of standardized human gut microbiota that is > 99% bacteria and prepared as previously described using stool from healthy individuals as starting material [37]. Briefly, donors underwent rigorous screening that involved regular questionnaires, review of medical history, and physical examinations to rule out infectious disease, metabolic syndrome, gastrointestinal disorders, and neurologic or neurodevelopmental problems.

    Serologic testing was performed to rule out infection with human immunodeficiency virus-1 and -2; hepatitis A, B, and C; and syphilis. The stool used in preparation was tested for potential bacterial pathogens (C. difficile toxin B, Campylobacter, Salmonella, toxin-producing Escherichia coli, Vibrio, Yersinia, Listeria, methicillin-resistant Staphylococcus aureus, and vancomycin-resistant Enterococcus), potential parasites (Giardia, Cryptosporidium, Cyclospora, and Isospora), and potential viral infections (Rotavirus A, Adenovirus, and Norovirus). Metabolic health of donor individuals was assessed with physical examinations and serologic testing (fasting glucose, lipid panel, liver function tests, and high sensitivity C-reactive protein).

    In addition, the fluorescent antinuclear antibody was employed as a screen for autoimmunity risk. Any single abnormality resulted in disqualification of the donor and prevents material release. The donated material was then extensively filtered and standardized under anaerobic conditions, following FDA good manufacturing processes (GMP), resulting in > 99% microbiota.

    The final product was in liquid form which can be frozen and was proven to be highly effective for treating C. difficile [37]. The SHGM was stored in −80 °C freezers at Arizona State University (ASU), and then delivered to families on dry ice every week during the study. Families were instructed to keep the SHGM in a container with dry ice and thaw it shortly before use.

    -

    As far as the paper goes, it looks awesome. Big effect size and high statistical significance despite the small sample size. Obvious implications for CFS. I'd try this in a heartbeat if it was offered.
     
    Last edited: Jan 26, 2017
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  3. Cheesus

    Cheesus Senior Member

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    This study seems to suffer from the core problem that we consistently criticise PACE for: it is an unblinded trial with subjective outcomes. Further to that, there was no control group, the sample size was very small and the follow-up was only two months.

    I'd be delighted if more research could be done in this area for autism, as it seems to be an intriguing hypothesis. However this study is seriously lacking and we would not let it fly for one second if it were an ME trial of a psychological therapy.
     
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  4. Murph

    Murph :)

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    Interesting point about the control group. There was a control group of sorts, but they were healthy and they didn't treat them. I guess patient collection was expensive and they wanted to make the sample size as big as possible? Maybe ethics committee questions too when dealing with kids?

    I also wish they followed up for longer and I agree it's way too soon to make treatment recommendations based on this. I see studies like this as cheap preliminary ones that serve to guide future research, not treatment.

    That also more or less describes the Rituximab Phase II trial... ;)

    Also worth noting is that some sub-outcomes actually are objectively measured (microbiome diversity.)
    and happily the paper calls at the end for a bigger, blinded trial! Which I'd love to see done. :)
     
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  5. Cheesus

    Cheesus Senior Member

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    @Murph

    Yes, there were some objective outcomes. It was really the clinical symptoms I was referring to.

    I think we can agree that we would both be happy for larger and more robust trials in this area.
     
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  6. Sidereal

    Sidereal Senior Member

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    Asking parents to rate their children's symptoms could beef up your results in the positive direction. Wishful thinking bias is just human nature I'm afraid. I think studies in this area should use blinded psych observers to rate behaviour. Not ideal either of course.
     
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  7. Sidereal

    Sidereal Senior Member

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    Well, at least they used a placebo control (saline infusion).
     
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  8. A.B.

    A.B. Senior Member

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    Again one ponders how a blinded trial of FMT would look like.
     
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  9. AndyPR

    AndyPR Senior Member

    Unappetizing?? ;)
     
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