Positive results from MS whipworm trial!

Apuman · Post by **Apuman** » Tue Mar 08, 2011 7:28 am

These results are from a trial in Wisconsin that tested the effectiveness of human whipworm and their modification of disease activity in PWMS. Thanks to Dignan for sharing.

Mult Scler. 2011 Mar 3. [Epub ahead of print]
Probiotic helminth administration in relapsing-remitting multiple sclerosis: a phase 1 study.

Fleming J, Isaak A, Lee J, Luzzio C, Carrithers M, Cook T, Field A, Boland J, Fabry Z.

Department of Neurology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Abstract

Background: Probiotic treatment strategy based on the hygiene hypothesis, such as administration of ova from the non-pathogenic helminth, Trichuris suis, (TSO) has proven safe and effective in autoimmune inflammatory bowel disease.

Objective: To study the safety and effects of TSO in a second autoimmune disease, multiple sclerosis (MS), we conducted the phase 1 Helminth-induced Immunomodulatory Therapy (HINT 1) study.

Methods: Five subjects with newly diagnosed, treatment-naive relapsing-remitting multiple sclerosis (RRMS) were given 2500 TSO orally every 2 weeks for 3 months in a baseline versus treatment control exploratory trial.

Results: The mean number of new gadolinium-enhancing magnetic resonance imaging (MRI) lesions (n-Gd+) fell from 6.6 at baseline to 2.0 at the end of TSO administration, and 2 months after TSO was discontinued, the mean number of n-Gd+ rose to 5.8. No significant adverse effects were observed. In preliminary immunological investigations, increases in the serum level of the cytokines IL-4 and IL-10 were noted in four of the five subjects.

Conclusion: TSO was well tolerated in the first human study of this novel probiotic in RRMS, and favorable trends were observed in exploratory MRI and immunological assessments. Further investigations will be required to fully explore the safety, effects, and mechanism of action of this immunomodulatory treatment.

http://www.ncbi.nlm.nih.gov/pubmed/21372112

mrbarlow · Post by **mrbarlow** » Tue Mar 08, 2011 9:27 am

The phase II trials only started in January, indeed I recall a poster called Egggirl saying she was in the trial. I asked her to keep us posted but I dont think she has.

This paper must relate to the earlier phase I trial?

Cece · Post by **Cece** » Tue Mar 08, 2011 3:18 pm

Small number of patients but impressive results. I am interested in phase II....

Wonderfulworld · Post by **Wonderfulworld** » Wed Mar 09, 2011 1:20 pm

Me too!

patientx · Post by **patientx** » Fri Apr 01, 2011 7:47 am

The full article is now available online, though you might have to pay for it. It looks like it's supposed to be in an issue of Multiple Sclerosis Journal, but it's not in the current (March) issue.

One reason that I wanted to read the full article was that I was surprised (and maybe a little skeptical) that they were reporting such dramatic changes in the number of Gd enhancing lesions. But, sure enough, 3/5 subjects did see a decline in the number of new lesions while taking the helmiths, and 4/5 saw an increase once treatment was stopped. (One of the inclusion criteria was evidence of Gd-enhancing lesions at study entry).

One person had 15 lesions at study entry, and another had 11 lesions and that number rose to 19! That's some pretty inflammatory activity.

Lyon · Post by **Lyon** » Fri Apr 01, 2011 8:35 am

patientx · Post by **patientx** » Fri Apr 01, 2011 8:54 am

Thanks for the link, Bob. I had managed to get the full article, but I'm sure others will be interested in reading it. I guess I should have written that I only recently came across the full thing (I think when this was first posted only the abstract was available).