Bob's worms are hatching!

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Bob's worms are hatching!

Postby dignan » Sat May 02, 2009 4:38 pm

Here is a helminth abstract from the AAN meeting, not sure if it has been posted already...


A Phase 1 Trial of Probiotic Helminth Ova in Relapsing Remitting Multiple Sclerosis (RRMS)

John Fleming, JangEun Lee, Christopher Luzzio, Michael Carrithers, Aaron Field, Zsuzsanna Fabry, Madison, WI

OBJECTIVE: To investigate the safety of probiotic helminth ova in subjects with RRMS.

BACKGROUND: The hygiene hypothesis has been advanced as a possible factor in the etiology and pathogenesis of allergic and autoimmune diseases, including multiple sclerosis. The hygiene hypothesis proposes that evolutionarily unnatural levels of high sanitation in developed countries may contribute to abnormal development and regulation of the immune system. In this regard, Summers and colleagues demonstrated that oral administration of non-pathogenic helminth Trichuris suis ova (TSO) was safe and effective in inflammatory bowel disease (Gastroenterology 2005;128:825-832).

DESIGN/METHODS: To study the effects of TSO more generally, in a second autoimmune disease, a pilot safety trial was conducted in five treatment-nave relapsing remitting multiple sclerosis (RRMS) subjects by means of oral administration of 2,500 ova every two weeks for three months. TSO production and administration were conducted under good manufacturing procedures, extensive microbiological sterility testing, university IRB approval, and an investigator IND from the US FDA.

RESULTS: Monitoring of clinical (EDSS, MSFC, relapses), gastrointestinal (symptom questionnaire, stool ova and parasite), neuroimaging (MRI), and immunological (T regulatory cells, cytokines) parameters did not identify any safety concerns in the five subjects during three months of TSO administration. Detailed results of MRI and immunological data will be reported.

CONCLUSIONS/RELEVANCE: The results of this exploratory study provide a preliminary indication of safety of TSO in RRMS. The findings justify further investigation of putative treatments based on the hygiene hypothesis in multiple sclerosis, including longer-term trials and study of the immunological mechanisms of TSO action. Supported by: National Multiple Sclerosis Society

http://www.abstracts2view.com/aan2009se ... 9L_P07.141
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Postby Lars » Sat May 02, 2009 6:23 pm

Hey Bob,
Not to beat a dead horse, but really, leaky gut syndrome and Enzyme therapy seem to be aimed towards the same end point. I anxiously await the counterpoint.
Be Well,
Lars
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Postby Lyon » Sun May 03, 2009 8:09 am

Thanks dignan. I'm not aware of that info having already been posted and I wasn't aware of it's existance. I was notified at thisisms by you or someone else some time ago that the first phase of the trial was over and that Dr Fleming was enrolling for phase two with 15 or 16 participants.

Lars wrote:Not to beat a dead horse, but really, leaky gut syndrome and Enzyme therapy seem to be aimed towards the same end point. I anxiously await the counterpoint.
Hi Lars,
I don't think I'm qualified to offer a counterpoint in those regards.

First, leaky gut isn't universally considered a legitimate condition and if/when it's legitimacy is confirmed it could still be considered a secondary factor caused by the loss of "evolutionary normal conditions" in developed populations.

I'm not familiar with enzyme therapy but the list of factors which might be considered as constituting "evolutionary normal conditions" is far from complete at this point and might ultimately include the loss of certain enzymes. I suppose returning those specific enzymes to the human system might be considered therapy?

Sorry Lars, I'm not sure the factors we're discussing are necessarily contrary :oops:
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Postby Lars » Sun May 03, 2009 8:51 am

Bob,
I don't think the viewpoints are contrary at all. Maybe just different road signs on the same highway. Enzyme Therapy was very much in the picture some years ago but like most Holistic answers, it was not widely accepted by Western medicine as an effective MS therapy, which is exactly why I am becoming more interested. Along with clearing foreign immune complexes, Enzyme Therapy also addresses digestive health. http://library.thinkquest.org/24206/enzyme-therapy.html
P.S.
I think technically, Hookworms would be considered Holistic as well.
Take Care,
Lars
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Postby dignan » Sun May 03, 2009 9:19 am

Bob, thanks for that update. I just checked clinicaltrials.gov and, of course, you're right, Fleming has moved to a phase 2 trial. I'll have to update the list.
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Postby Lyon » Sun May 03, 2009 10:00 am

dignan wrote:Fleming has moved to a phase 2 trial. I'll have to update the list.
Thanks dignan! I purposely have been refraining from contacting John during the clinical trial process because I'm not good at keeping secrets, so I don't have any inside information other than his mention that he wasn't going to proceed with phase II unless phase I was promising. That alone is interesting because he's a reluctant believer....if he could be called a believer.
Lars wrote:P.S.
I think technically, Hookworms would be considered Holistic as well.
:lol: I've never been comfortable with the mindset or term holistic but I have to agree that helminths would have to go under that definition.

In my mind the difference is that (I'm convinced) through evolutionary history the human system has developed a dependence on the excretions/secretions of the helminths we shared our bodies with through evolution and I think very seldom/if ever do other "holistic" factors involve evolved dependencies.

Very interesting subject though and impossible to answer at this time.
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