Volunteers Needed for UW-Madison Clinical Trial of Multiple Sclerosis Therapy

Madison, Wisconsin - It sounds like a challenge from "Fear Factor," but an initial study has suggested that introducing tiny intestinal parasites into patients with multiple sclerosis (MS) may help quell the progression of the disease.

Patients newly diagnosed with MS can volunteer for the second trial of the probiotic therapy, which has also shown promise for other autoimmune diseases.

Participants will drink a sports drink with an added ingredient - the nearly invisible eggs of a small creature called a helminth (a type of whip worm) that live briefly in the digestive tract. The purified eggs come from a German company.

Dr. John Fleming, a neurology professor at the University of Wisconsin School of Medicine and Public Health, said his first-round trial of the substance in 2009 showed promising clinical, immunological, and MRI results. Participants reported no significant side effects.

"The pilot study showed that the treatment seems to be safe and well-tolerated, but since it only involved five participants, we need more data before we can decide whether this is both a safe and effective treatment for MS," Fleming says.

The therapy is based on the "hygiene hypothesis," which holds that people in developed countries are much more likely to develop autoimmune diseases because they are not exposed to the mild and common infections that children acquire in the developing world, where autoimmune diseases are rare.

In multiple sclerosis, the immune system attacks the fatty tissue surrounding nerves in a person's brain or spinal cord, disrupting messages between the brain and the body.

In addition to multiple sclerosis, helminth therapy is being tested in cases of asthma and allergic rhinitis, and has already been shown effective in autoimmune diseases of the digestive system, such as Crohn's disease and ulcerative colitis.

For the Helminth-Induced Immunomodulation Therapy (HINT II) trial, researchers at UW-Madison and the Marshfield Clinic hope to try the therapy with about 18 patients. The trials are expected to begin in late spring or early summer and last about 10 months. Dr. Loren Rolak, a Marshfield Clinic neurologist, is heading the trials there.

Before the trial, participants will have a baseline MRI scan to check for the brain lesions associated with the disease, then will have follow-up scans during the trial.

"We are looking for participants who have newly diagnosed relapsing-remitting MS and haven't had other treatments," Fleming says. "They should also live within driving distance of either Madison or Marshfield."

The trial is being funded by the National Multiple Sclerosis Society.