Open US (South Florida): The Use of Directed Probiotics in ME/CFS

[Tom Kindlon]

https://www.nova.edu/nim/research-s...ages/INIM-studies/kaneka-probiotic-study.html
The Use of Directed Probiotics in ME/CFS
In this virtual study, we aim to use the probiotic, Floradapt Intensive GI (other name i3.1), to reduce gastrointestinal (GI) inflammation and normalize the GI, to determine whether resetting your microbiome will help your gut health and perhaps your body as well while simultaneously assessing the effectiveness and safety of this intervention based on the severity of illness.

Who can Participate?
INIM Researchers will evaluate the use of probiotics in 100 participants who:

• Are between 45 to 70 years of age
• Meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS
• May or may not be diagnosed with irritable bowel syndrome (IBS)

For more information, please email KanekaStudy@nova.edu.
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To facilitate sharing:

 

[Denise]

"Meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS"
The IOM criteria are not the CCC.
Did they leave out "or" in front of Canadian....?

 

[Helene]

To participate in the study you need to be in South Florida for blood draws.

Here's the reply I got in response to my inquiry:
"Unfortunately, we need to have our patients locally in South Florida at either INIM Davie Clinic or Kendall Clinic for two blood drawers.
We are sorry that you will not be able to participate in this study. Please let us know if you have any other ME/CFS patients who would be interested in this Study.
Regards,
Anthony Park
Doctor of Osteopathic Medicine (D.O.)
Clinical Study Coordinator, Institute of Neuro-Immune Medicine
NSU Dr. Kiran C. Patel College of Osteopathic Medicine
Phone: (801) 910-0491
Email: KanekaStudy@nova.edu"
Edited to add missing word.

 

[Hutan]

Can someone ask where the study is registered e.g. on Clinical Trials?

I think any researcher advertising to recruit for a trial should include a link to the study's entry in a common trial registry.

 

[cassava7]

Can someone ask where the study is registered e.g. on Clinical Trials?

I think any researcher advertising to recruit for a trial should include a link to the study's entry in a common trial registry.

I had a short mail exchange with Dr Park and they haven’t registered the study nor published its protocol. It has received ethical approval.

I am concerned that Dr Park told me “[the] result will be shared through Kaneka Probiotic Company once [the study] is done.”

 

[Trish]

That's concerning. So although they are calling it a clinical trial, it's really more of a marketing exercise, and unlikely to be subject to peer review. And probably not published at all if they get negative results.

 

[Jaybee00]

Ugh. Hopefully they (Kaneka) are paying subjects since Kaneka is the beneficiary here.

 

[forestglip]

Here's the ClinicalTrials.gov registration:

The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome