Dr Nath's intra-mural study at NIH is currently recruiting

[viggster]

Also, 10 healthy volunteers and 10 patients have gone through part 1 of the protocol. Two healthy volunteers have completed part 2 (metabolic chamber and exercise test).

The biopsy protocols are going through IRB review (institutional review board, which has to approve changes to the study).

 

[Jesse2233]

@viggster thanks for the update, do you know if they're looking for both pathogens and metabolites in the tissue biopsies?

 

[Groggy Doggy]

Also, 10 healthy volunteers and 10 patients have gone through part 1 of the protocol. Two healthy volunteers have completed part 2 (metabolic chamber and exercise test).

The biopsy protocols are going through IRB review (institutional review board, which has to approve changes to the study).

Thank you for keeping us informed on NIHs progress in the ME intramural study. I applaud the work that NIH is doing! And as a bonus, they are moving at a faster pace than originally planned.

Do you know if there will be any data sharing between the newly announced NIH grant funded ME research centers and the NIH Intramural study?

 

[RYO]

I will be heading back to NIH for phase 2 this winter. They are working on details of muscle and skin biopsy. I am hoping to recover somewhat from severe relapse before exercise challenge. I hope they include electron microscopy of muscle tissue. I asked about preliminary data. I was told early reports will likely not be available. I forwarded link to Dr Davis's recent symposium to NIH. I didn't get the impression that there will be any data sharing. However, it will interesting if they reveal similar findings.

 

[frozenborderline]

is this study still recruiting?

 

[Never Give Up]

is this study still recruiting?

Yes. The contact info is here:

https://clinicaltrials.gov/ct2/show/NCT02669212

 

[RYO]

Slightly off topic but I learned today that Discovery Channel has new series called First in Human (Building 10). It gives the viewer a look into what it is like to be enrolled in a clinical trial at NIH Center. Watching the episodes makes you appreciate the history of NIH and gives you a glimpse into the poignant personal stories of rare and difficult to treat diseases.

https://www.discovery.com/tv-shows/first-in-human/

 

[Wally]

Just learned that NIH is adding skin & muscle biopsies to the intramural study. This is good news...it shows they have flexibility to adapt as they see more patients and get a deeper understanding of the problems patients have.

@viggster - Do you know if they are planning to biopsy any of the lymph glands? If yes, do you know if this will include biopsy of lymph glands located in the neck?

 

[viggster]

@viggster - Do you know if they are planning to biopsy any of the lymph glands? If yes, do you know if this will include biopsy of lymph glands located in the neck?

I don't think so. NIH staff told me they plan skin + muscle biopsies.

What would you want to look for in lymph nodes? Those are typically biopsied in various cancers.

 

[halcyon]

What would you want to look for in lymph nodes? Those are typically biopsied in various cancers.

It's a great place to look for pathogens. Stanford ME/CFS Initiative studies will be looking at lymph node aspirates.

 

[RYO]

It's a great place to look for pathogens. Stanford ME/CFS Initiative studies will be looking at lymph node aspirates.

I would be willing to undergo lymph node aspirate although I do not have any lymphadenopathy. Also, I think stomach biopsy may yield interesting findings since many ME/CFS patients have GI symptoms.