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Fecal matter transplant
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==Evidence== ===Critique of Borody study using FMT for chronic fatigue syndrome=== A 2012 study by Borody, at el, using a variety of antibiotics followed by one to three fecal matter transplants (and in six patients an oral course of cultured bacteria), reported a 70% rate of improvement of sleep and "lethargy/fatigue" symptoms in [[Fukuda criteria|Fukuda]] CFS patients recruited from a clinic for digestive disorders.<ref name=":1">{{Cite journal | last = Borody | first = Thomas J | author-link = | last2 = Nowak | first2 = Anna | authorlink2 = | last3 = Finlayson | first3 = Sarah | date = Dec 2012 | title = The GI microbiome and its role in Chronic Fatigue Syndrome: A summary of bacteriotherapy| url = https://search.informit.com.au/documentSummary;dn=119626231492520;res=IELHEA|journal=Journal of the Australasian College of Nutritional and Environmental Medicine|volume=31|issue=3 | pages = 3-8|quote=|via=}}</ref> The authors reported a 58% success rate at long term followup 15-20 years post-treatment, but only 12 patients (out of the original 60) were contacted at that point. Accordingly, the long-term followup results would not have been statistically significant. That study also neglected to use any objective outcome measurements, a control group was not included, and the symptoms used to determine a successful outcome regarding "CFS symptoms" did not account for physical limitations or many other fundamental ME/CFS symptoms. It is not clear how many symptoms were measured before and after treatment, hence it cannot be determined if any results were statistically significant. Furthermore, all patients were recruited from a clinic for digestive disorders, which would suggest that they were not typical ME/CFS patients. The recruitment criteria did not require that patients have the symptom of [[post-exertional malaise]], hence the results may not be applicable to ME/CFS patients meeting more stringent criteria. There was no study protocol published, and there is no explanation provided for the results first being published as a full paper fifteen years after the initial treatments took place. A conference poster abstract from 1995 indicates that other symptoms were tested at an earlier followup,<ref>{{Cite journal | last = Borody | first = TJ | author-link = | date = 1995 | title = Bacteriotherapy for Chronic Fatigue Syndrome β A long-term follow-up study | url = |journal=Proceedings of ACMA Complementary Medicine Sydney 1995|volume=|issue=| pages=|quote=|via=}}</ref> but those symptoms are not reported or discussed in the 2012 long-term followup, which may indicate that the treatment was less successful than reported. The poster abstract does not appear to have been published, and the full long-term followup was published in an obscure online journal with no apparent peer review process. This study has not been replicated, and no other studies for FMT and ME/CFS have been conducted. Accordingly, the existing evidence base in favor of this therapy is very weak. ===RESTORE-ME clinical trial=== A feasibility study for a clinical trial of FMT for patients with ME/CFS is in progress in the UK, with support and funding from the charity [[Invest in ME Research]].<ref name="quadram-trial">https://quadram.ac.uk/restore-me-trial-event/</ref> The study is led by [[Simon Carding]] or the [[Quadram Institute]]. The RESTORE-ME clinical trial aims to find out if FMT will restore a healthy gut microbiome in ME patients, and to find out if this improves physical and mental health of those with ME.<ref name="Carding2020-slides">{{Cite web | url=https://quadram.ac.uk/wp-content/uploads/2020/02/ME-Public-Event-2020-all-slides-v8-final-for-website.pdf | title=Gut Microbes, FMT and ME | last = Carding | first = Simon | author-link = Simon Carding|website=Quadram Institute | date = Feb 2020}}</ref> This is a double-blinded, randomized controlled trial in phase IIb, and involves 160 mildly/moderately ill ME patients.<ref name="Carding2020-slides" /> It was expected to begin in September 2020, but this has been altered due to the COVID-19 pandemic.<ref name="Carding2020-slides" />
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