Restless Legs Syndrome Study

The purpose of the study is to determine if having too many bacteria in the small intestine is related to Restless Legs Syndrome (RLS), and if treatment with a non-absorbable antibiotic called Xifaxan will help. A significant percent of people with RLS also have gastrointestinal symptoms including bloating, gas, abdominal pain and change of bowel habits. Recent studies have shown that people who have these gastrointestinal symptoms frequently have small intestinal bacterial overgrowth and treatment with Xifaxan helped improve both RLS and gastrointestinal symptoms.

You can be eligible for the RLS study if a breath test that reflects bacterial overgrowth is positive.  To be eligible in the study you would need to have mild to moderately severe RLS. You would still be able to continue all of your current medication. 

The main condition that would exclude you from participating in the study includes having the following: antibiotics or probiotics (good bacteria pills) within 6 weeks of the study.

The “placebo controlled, double blind randomized medicine” study would involve coming to Dr. Weinstock’s office located in Creve Coeur for up to two visits over a period of three weeks. The first of these visits will take 3 hours and would include filling out questionnaires, taking a blood sample, and a doing breath test.  The breath test takes 3 hours and needs to be repeated after the 10 days of medicine therapy.  Two sets of questionnaires will be filled out at home at day 20 and day 30.

The odds of getting the antibiotic versus placebo are 2 to 1. The costs of the office visit and the breath tests will be submitted to your insurance company and we will take what insurance will pay so that there are not additional charges to you. There is a charge by the lab for the blood tests which measure your blood count and the ferritin (iron) level (we are able to use these blood test results if they have recently been performed).

CONSENT FORM for placebo controlled randomized medicine study

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