Open Australia - Victoria: “Bottom-up”: linking the gut microbiota, immune system and metabolism in ME/CFS - Missailidis, La Trobe

Hi everybody, I finally have the ethics in place to begin recruiting for our recently funded Mason Foundation study.

ICC criteria. Healthy controls and pwME in VIC, Australia. Involves some questionaires and a blood and feces collection. We will home visit severely affected people.

Primary point of contact will be me by email and questions will be answered most reliably by this method, I may miss forum posts or social media (D.Missailidis@latrobe.edu.au).

Informed consent and full details will be provided upon establishing contact.

Study will do functional immune cell and circulating cytokine profiling with new methods, gut microbiota profiling with new methods including organisms not yet looked for, immune cell energy profiling, circulating and gut targeted metabolite quantitation based on a hypothesis from unpublished data. Will be capped off with a novel drug target and biomarker bioinformatics pipeline to inform subsequent investigation.

Feel free to send on to people or groups that may be interested. The more people this reaches, the better our sample size might be.

Study ad: https://docs.google.com/document/d/...ouid=106411990730824976565&rtpof=true&sd=true

 

Sorry I am not in Australia, but a big shout out that you are including people with severe ME.

 

Great news . I've posted to closed Facebook groups this morning and hope you get good recruitment

 

Likewise, posted on closed FB and on social media. Not on Twitter tho so hopefully others will post there.

 

I only wish that there was a way to access those too severe to use the internet beyond lucking out with their carers.

Thank you everybody else for your support and spreading it, it has shown in huge spikes in responses since I woke up this morning. It really helps and matters a lot. Especially since our local clinical contacts have become diminished by events in the last half decade or so.

I have had a very stressful day for unrelated reasons and your assistance is a balm. Sincerely, thank you.

 

Mind it is good you recognise the very very severe exist, here in the UK at times it seems like researchers are not even willing to acknowledge such people exist.

 

I have requested for it to be added to the crunchme database. If it isn't too much effort, which I don't know, perhaps it would be an option to have the study registered on ClinicalTrials.gov? In that case it will automatically appear on resources such as https://longcovidstudies.net/.

 

Hadn't thought of this, I will look into it, thank you.

On another note, if anybody has family or friends who may be interested as healthy controls please put them in touch @ D.Missailidis@latrobe.edu.au . Similarly if anybody with access to closed pwME networks could share this message it would be IMMENSE. $20 is available to reimburse every participant.

I hate to ask pwME to do things, but these communities are really a lifeline for these projects and I want to get our cohorts well-populated and without the demographic biases of my personal networks where possible.

 

Is there a concern that if family members of ME participants are included as healthy volunteers, there may be some confounding factors? I'm just thinking of the families where multiple members are hit with ME after a virus passes through the family, and also of the possibility that some people have a mild form of ME that they don't recognise as illness (I didn't realise I was sick for the first 8 years or so) or that a genetic predisposition is involved in this disease process. The NIH study, which I think used family members for healthy volunteers, found a surprising number of them to have orthostatic intolerance, right?

 

We have intentionally excluded family in the past so trust me I understand. We will exclude family members with known history of similar or relevant conditions (including POTS, we will never treat anybody with POTS as a healthy control). I anticipate that we will have very few if any family members as controls in any case. And I will treat them separately in the analysis.

It may even open up potential paired comparisons or small case study analyses in parallel to the main study. Eg: a scenario where two people cohabit, are of same gender and similar age, and have similar diet / environment which leads to similar microbiota profiles. If they did have very similar or identical microbiota profiles (and one has disease and one doesn’t) it could be grounds to suggest that the particular disease case is not caused by or measurably interacting with that person’s microbiota profile. It could also mean that the apparently healthy family member is predisposed or prodromal. It is all grist for the mill

rest assured they will not just be lumped into a healthy control pile. I tag all of these things with variables and analyse them appropriately depending on the situation.

i would rather have them and set them aside in analysis to look at them separately than just have fewer samples. Committed funding for this study should be enough to handle it all either way, wont be a waste of resources.

 

If only the NIH had had your clear, comprehensive and ethical pre-trial conceptions. (sigh) Maybe you could teach them a thing or two or three....

 

If anybody knows someone very experienced and composed at taking blood in VIC, please send them my way. We need a phlebotomist for the severe pwME home visits. I want someone really good so that things go smoothly for our participants. (Our previous people have moved on). They will be paid for their time, of course.

 

A tip for blood drawing to go smooth. A baby needle makes it a lot easier. A baby needle with a bit of a push to get in works for me.
A normal needle only pushes the vein away or leaves big dark bleu bumps.

 

Will discuss with the person we settle on

 

@DMissa - do you have a sense of when participants might be contacted for collection?